Heartware recalls
Heartware appears in 75 official U.S. recall notices indexed by RecallRadar, most recently on 2023-12-13.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 75 |
|---|---|
| Published | 2013-05-22 to 2023-12-13 |
| By agency | FDA Device (75) |
| By classification | Class I (38), Class II (37) |
| By status | ongoing (66), terminated (9) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
FDA Device · Class II · 2023-12-13 · Heartware
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended tr… - 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
FDA Device · Class II · 2023-12-13 · Heartware
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended tr… - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
FDA Device · Class II · 2023-12-13 · Heartware
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended tr… - HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
FDA Device · Class II · 2023-12-13 · Heartware
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended tr… - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
FDA Device · Class II · 2023-12-13 · Heartware
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended tr… - HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
FDA Device · Class II · 2023-12-13 · Heartware
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended tr… - STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
FDA Device · Class II · 2023-12-13 · Heartware
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended tr… - PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
FDA Device · Class II · 2023-12-13 · Heartware
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended tr… - PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
FDA Device · Class II · 2023-12-13 · Heartware
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended tr… - HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech,…
FDA Device · Class II · 2023-06-28 · Heartware
Reason: Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal. - HeartWare Model 1100
FDA Device · Class II · 2022-12-28 · Heartware
Reason: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which ma… - HeartWare HVAD Pump Kit, REF MCS1705PU
FDA Device · Class II · 2022-12-28 · Heartware
Reason: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which ma… - HeartWare HVAD Pump Kit, REF 1104JP
FDA Device · Class II · 2022-12-28 · Heartware
Reason: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which ma… - HeartWare HVAD Pump Kit, REF 1104CA-CLIN
FDA Device · Class II · 2022-12-28 · Heartware
Reason: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which ma… - HeartWare Model 1101
FDA Device · Class II · 2022-12-28 · Heartware
Reason: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which ma… - HeartWare HVAD Pump Kit, REF 1104
FDA Device · Class II · 2022-12-28 · Heartware
Reason: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which ma… - HeartWare HVAD Pump Kit, REF 1205
FDA Device · Class II · 2022-12-28 · Heartware
Reason: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which ma… - HeartWare Model 1102
FDA Device · Class II · 2022-12-28 · Heartware
Reason: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which ma… - HeartWare HVAD Pump Kit, REF 1103
FDA Device · Class II · 2022-12-28 · Heartware
Reason: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which ma… - HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
FDA Device · Class I · 2022-08-24 · Heartware
Reason: Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while dischargin… - HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
FDA Device · Class II · 2022-05-25 · Heartware
Reason: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. - HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
FDA Device · Class II · 2022-05-25 · Heartware
Reason: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. - HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
FDA Device · Class II · 2022-05-25 · Heartware
Reason: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. - HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
FDA Device · Class II · 2022-05-25 · Heartware
Reason: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. - HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
FDA Device · Class II · 2022-05-25 · Heartware
Reason: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. - HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System E…
FDA Device · Class II · 2022-05-25 · Heartware
Reason: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. - HeartWare Ventricular Assist Device (HVAD) System
FDA Device · Class II · 2022-03-16 · Heartware
Reason: Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is ap… - Medtronic HVAD Pump Implant Kits
FDA Device · Class II · 2021-09-22 · Heartware
Reason: There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in p… - HeartWare HVAD Driveline Extension Cable, REF 100
FDA Device · Class I · 2021-08-18 · Heartware
Reason: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with t… - HeartWare HVAD Pump Implant Kit, REF 1125
FDA Device · Class I · 2021-08-18 · Heartware
Reason: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with t… - HeartWare HVAD Pump Implant Kit, REF 1153
FDA Device · Class I · 2021-08-18 · Heartware
Reason: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with t… - HeartWare HVAD Driveline Extension Cable, REF 100US
FDA Device · Class I · 2021-08-18 · Heartware
Reason: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with t… - HeartWare HVAD Implant Kit, REF 1104JP
FDA Device · Class I · 2021-08-18 · Heartware
Reason: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with t… - HeartWare HVAD Implant Kit, REF MCS1705PU
FDA Device · Class I · 2021-08-18 · Heartware
Reason: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with t… - HeartWare HVAD Pump Implant Kit, REF 1103
FDA Device · Class I · 2021-08-18 · Heartware
Reason: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with t… - HeartWare HVAD Pump Accessories, REF MCS1753AK
FDA Device · Class I · 2021-08-18 · Heartware
Reason: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with t… - HeartWare HVAD Pump Implant Kit, REF 1104
FDA Device · Class I · 2021-08-18 · Heartware
Reason: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with t… - HeartWare HVAD Outflow Graft, REF MCS1725OG
FDA Device · Class I · 2021-08-18 · Heartware
Reason: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with t… - HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory le…
FDA Device · Class II · 2021-07-21 · Heartware
Reason: The pump has an impeller with a shroud height that did not meet the lower control limit. - Instructions for Use and Patient Manual for HeartWare HVAD System
FDA Device · Class II · 2021-04-28 · Heartware
Reason: IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermitte… - Instructions for Use and Patient Manual for HeartWare HVAD System
FDA Device · Class II · 2021-04-28 · Heartware
Reason: IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep"… - Instructions for Use and Patient Manual for HeartWare HVAD System
FDA Device · Class I · 2021-04-28 · Heartware
Reason: Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clar… - Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 143…
FDA Device · Class I · 2021-04-14 · Heartware
Reason: There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cable… - Medtronic HVAD Alarm Adapter, Product Number: 1450
FDA Device · Class I · 2021-04-14 · Heartware
Reason: There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cable… - Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 140…
FDA Device · Class I · 2021-04-14 · Heartware
Reason: There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cable… - Medtronic HVAD Monitor Data Cable, Product Number: 1575
FDA Device · Class I · 2021-04-14 · Heartware
Reason: There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cable… - Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
FDA Device · Class I · 2021-04-14 · Heartware
Reason: There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cable… - Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511I…
FDA Device · Class I · 2021-04-14 · Heartware
Reason: There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cable… - Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Mo…
FDA Device · Class I · 2021-02-10 · Heartware
Reason: Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substant… - Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
FDA Device · Class I · 2020-06-03 · Heartware
Reason: The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.