FDA (Devices) recall action 92328
The FDA (Devices) publishes a recall like this one as 120 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 120 pages.
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic's EVERA XT implantable cardioverter defibrillators may fail to deliver therapy due to a rare feedthrough defect affecting 727 units worldwide.
Medtronic implantable heart defibrillators may fail to deliver therapy during emergencies. The rare defect affects 510 devices distributed nationwide and worldwide.
Medtronic is recalling certain CRT-D (cardiac resynchronization therapy defibrillator) models due to a rare risk of reduced or no energy output during high-voltage therapy. The FDA has classified this as a Class I recall affecting 1,473 units.
Medtronic implantable cardiac defibrillators (CRT-D) may deliver reduced or no energy during critical high-voltage therapy due to a feedthrough defect. The recall affects 193 units that could fail to deliver lifesaving defibrillation shocks when needed.
Medtronic's ICD and CRT-D devices may fail to deliver high-voltage therapy due to a defect in a specific feedthrough component. Patients should contact their healthcare provider immediately to discuss the risk.
Medtronic's ICD-VR DVMB2D4 implantable defibrillators may fail to deliver electrical therapy due to a defect in the feedthrough component. The recall affects 6,477 units distributed worldwide.
Medtronic implantable cardioverter defibrillators (ICDs) may fail to deliver high-voltage therapy due to a manufacturing defect in a specific feedthrough component. 447 units are affected worldwide.
Medtronic is recalling 522 implantable cardioverter defibrillators that may deliver reduced or no energy during high-voltage therapy due to a feedthrough defect.
Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a defective feedthrough component. The FDA classified this as a Class I recall affecting 2,884 devices.
Medtronic is recalling 661 CRT-D implantable defibrillators due to a rare manufacturing defect that may reduce or eliminate energy output during therapy delivery. Affected devices may fail to deliver necessary electrical treatment during cardiac emergencies.
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough design issue. This could prevent life-saving electrical therapy from being delivered.
Medtronic's implantable cardioverter defibrillators may produce reduced or no energy during high voltage therapy due to a feedthrough defect. A total of 1,076 units are affected worldwide.
Certain Medtronic implantable cardioverter defibrillators may deliver reduced or no energy during high voltage therapy due to a defective feedthrough. This defect could prevent the device from properly treating life-threatening heart rhythms.
Medtronic implantable defibrillators may fail to deliver therapy due to a feedthrough defect. 2,173 affected units were distributed nationwide and worldwide.
Medtronic recalled 22,114 ICD COBALT XT defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy delivery caused by a specific feedthrough defect.
Medtronic implantable cardioverter defibrillators with a specific feedthrough defect may rarely fail to deliver high-voltage therapy. Approximately 34,350 devices distributed worldwide are affected.
Certain Medtronic implantable cardioverter defibrillators may fail to deliver proper energy output during high-voltage therapy due to a feedthrough defect. Patients with affected devices should contact Medtronic immediately.
Medtronic has recalled certain implantable cardioverter defibrillators due to a rare risk of reduced or no energy output during high-voltage therapy.
Medtronic is recalling 14,270 implantable cardioverter defibrillators with a specific feedthrough that may produce reduced or no energy output during high-voltage therapy. The affected devices may fail to deliver critical treatment when needed.
Medtronic implantable cardiac defibrillators may fail to deliver electrical therapy during treatment due to a defective feedthrough component. Approximately 1,878 devices are affected.
Medtronic implantable cardioverter defibrillators with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially failing to deliver life-saving shocks.
Medtronic is recalling 289 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare potential defect that may prevent proper high-voltage therapy delivery.
Medtronic is recalling approximately 6,525 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may produce reduced or no energy output during high-voltage therapy, potentially preventing treatment delivery.
Medtronic implantable defibrillators may fail to deliver therapy due to a defective feedthrough component. 207 units recalled nationwide and worldwide.
Medtronic is recalling certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare risk of reduced or no energy output during high voltage therapy.