St Jude Medical recalls
St Jude Medical appears in 73 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG)…
FDA Device · Class II · 2017-07-19 · St Jude Medical
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. - Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG)…
FDA Device · Class II · 2017-07-19 · St Jude Medical
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. - Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to…
FDA Device · Class II · 2017-07-19 · St Jude Medical
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. - Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to…
FDA Device · Class II · 2017-07-19 · St Jude Medical
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. - Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to…
FDA Device · Class II · 2017-07-19 · St Jude Medical
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. - Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to…
FDA Device · Class II · 2017-07-19 · St Jude Medical
Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. - Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257…
FDA Device · Class I · 2016-11-02 · St Jude Medical
Reason: St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster wit… - Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD335…
FDA Device · Class I · 2016-11-02 · St Jude Medical
Reason: St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster wit… - Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fort…
FDA Device · Class I · 2016-11-02 · St Jude Medical
Reason: St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster wit… - Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD device…
FDA Device · Class II · 2016-05-18 · St Jude Medical
Reason: St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy. - TactiSys Quartz Pack, PN-004 400
FDA Device · Class II · 2015-03-25 · St Jude Medical
Reason: A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters. - St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
FDA Device · Class II · 2014-11-12 · St Jude Medical
Reason: St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within… - St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of…
FDA Device · Class II · 2014-10-29 · St Jude Medical
Reason: St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire c… - Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead)
FDA Device · Class II · 2014-10-08 · St Jude Medical
Reason: The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international man… - Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead)
FDA Device · Class II · 2014-10-08 · St Jude Medical
Reason: The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international man… - Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions dur…
FDA Device · Class II · 2013-11-20 · St Jude Medical
Reason: St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector… - US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only,…
FDA Device · Class II · 2013-11-13 · St Jude Medical
Reason: St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation C… - Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs inclu…
FDA Device · Class II · 2013-08-07 · St Jude Medical
Reason: As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery wel… - Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger)
FDA Device · Class II · 2013-07-31 · St Jude Medical
Reason: There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing… - Eon Mini - 3721 (Charger)
FDA Device · Class II · 2013-07-24 · St Jude Medical
Reason: St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their s… - Eon - 3701 (Wall Charger) and 3711 (Portable Charger)
FDA Device · Class II · 2013-07-24 · St Jude Medical
Reason: St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their s… - St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System
FDA Device · Class I · 2013-02-20 · St Jude Medical
Reason: The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions. - Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minn…
FDA Device · Class III · 2013-01-09 · St Jude Medical
Reason: St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the label…