St Jude Medical recalls
St Jude Medical appears in 73 official U.S. recall notices indexed by RecallRadar, most recently on 2025-04-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 73 |
|---|---|
| Published | 2013-01-09 to 2025-04-02 |
| By agency | FDA Device (73) |
| By classification | Class II (60), Class I (12), Class III (1) |
| By status | terminated (60), ongoing (13) |
| Distribution named in notices | CA, CT, FL, GA, IL, KS, KY, MA, MI, MN, NC, NJ, NY, OH, OK, OR, PA, TX, US, UT, WA |
Recalls
- CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM…
FDA Device · Class II · 2025-04-02 · St Jude Medical
Reason: Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient i… - Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model…
FDA Device · Class II · 2025-01-29 · St Jude Medical
Reason: Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings. - CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Networ…
FDA Device · Class II · 2025-01-29 · St Jude Medical
Reason: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings. - CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Netwo…
FDA Device · Class II · 2025-01-29 · St Jude Medical
Reason: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings. - St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
FDA Device · Class II · 2024-07-24 · St Jude Medical
Reason: One lot of product has dilators that are too short and will not extend outside the introducer sheath. - CardioMEMS Patient Electronic System (PES), Model Number CM1100
FDA Device · Class II · 2023-11-15 · St Jude Medical
Reason: Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees. - CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodyn…
FDA Device · Class II · 2023-03-15 · St Jude Medical
Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits… - CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynami…
FDA Device · Class II · 2023-03-15 · St Jude Medical
Reason: Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of th… - CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodyn…
FDA Device · Class II · 2023-03-15 · St Jude Medical
Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits… - CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodyn…
FDA Device · Class II · 2023-03-15 · St Jude Medical
Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits… - CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynami…
FDA Device · Class II · 2023-03-15 · St Jude Medical
Reason: Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of th… - CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemody…
FDA Device · Class II · 2023-03-15 · St Jude Medical
Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits… - CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynami…
FDA Device · Class II · 2023-03-15 · St Jude Medical
Reason: Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of th… - ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
FDA Device · Class I · 2019-08-14 · St Jude Medical
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact c… - ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
FDA Device · Class I · 2019-08-14 · St Jude Medical
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact c… - ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
FDA Device · Class I · 2019-08-14 · St Jude Medical
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact c… - ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
FDA Device · Class I · 2019-08-14 · St Jude Medical
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact c… - ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
FDA Device · Class I · 2019-08-14 · St Jude Medical
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact c… - ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
FDA Device · Class I · 2019-08-14 · St Jude Medical
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact c… - St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano,…
FDA Device · Class II · 2018-12-19 · St Jude Medical
Reason: The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium. - Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted de…
FDA Device · Class II · 2018-07-11 · St Jude Medical
Reason: The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitor… - St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and…
FDA Device · Class II · 2018-07-11 · St Jude Medical
Reason: The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitor… - Merlin PCS programmer (Model # 3650), Software (Model # 3330)
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095,…
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981
FDA Device · Class II · 2018-07-04 · St Jude Medical
Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of prot… - Proclaim DRG Implantable Pulse Generator, Model Number 3664
FDA Device · Class II · 2018-04-04 · St Jude Medical
Reason: The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfor… - PM 1250 and PM 2250 ZENEX
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. - Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimati… - PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the b…
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. - Anthem Model Numbers: PM3210, PM3212
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. - Proclaim DRG Implantable Pulse Generator Model 3664
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimati… - Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimati… - PM1214 NUANCE SR RF
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. - Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indi…
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. - Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable…
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. - PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be p…
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. - Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitt…
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. - PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be…
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. - Assurity Model Numbers: PM1240, PM2240
FDA Device · Class II · 2017-10-25 · St Jude Medical
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. - Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q
FDA Device · Class I · 2017-10-18 · St Jude Medical
Reason: The device may exhibit premature battery depletion. - Unify, Model Numbers: CD3231-40 and CD3231-40Q
FDA Device · Class I · 2017-10-18 · St Jude Medical
Reason: The device may exhibit premature battery depletion.