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 MIRRO MRI implantable cardioverter defibrillators with a specific glassed feedthrough may rarely fail to deliver adequate energy output during high-voltage therapy, affecting approximately 2,831 units distributed worldwide.
Certain Medtronic implantable cardioverter defibrillators with a specific feedthrough may produce reduced or no energy output during high voltage therapy. The rare defect affects 16 units distributed nationwide.
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy delivery due to a defective feedthrough component. No injuries have been reported, but patients may not receive proper treatment for life-threatening heart rhythms.
Medtronic is recalling 404 units of implantable cardioverter defibrillators and cardiac resynchronization devices due to a rare risk of reduced or absent energy output during therapy. The defect involves a specific manufacturing feedthrough component.
Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a specific feedthrough may fail to deliver high-voltage therapy. The FDA is recalling 28,172 units as a Class I safety issue.
Certain Medtronic implantable cardioverter defibrillators and CRT-Ds may fail to deliver adequate energy during high-voltage therapy due to a feedthrough component defect. This affects 5,215 units distributed worldwide.
Medtronic's implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may fail to deliver high-voltage therapy due to a defect in specific glassed feedthrough components. The FDA classified this as a Class I recall due to potential for serious harm.
Medtronic issued a Class I recall for certain implantable cardioverter defibrillators due to a rare risk that high-voltage therapy may not deliver. Affected models include DTMA1QQ devices made with a specific feedthrough component.
Medtronic implantable cardioverter defibrillators with specific feedthrough components may fail to deliver high-voltage therapy during treatment. Affected units are being recalled due to risk of reduced or absent energy output.
Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component. Affected devices were distributed nationwide and worldwide.
Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may deliver reduced or no energy during high-voltage therapy. The recall affects approximately 6,536 units with a specific feedthrough component.
Medtronic CRT-D and ICD devices with a specific feedthrough may fail to deliver high-voltage therapy. The FDA Class I recall affects multiple lot numbers due to rare potential for reduced or no energy output during critical treatment.
Medtronic recalls ICD COBALT VR MRI DF4 defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect affects devices manufactured with a specific glassed feedthrough component.
Medtronic recalls 3 COBALT XT implantable defibrillators that may deliver reduced or no energy during therapy. A defect in the device feedthrough could prevent effective treatment of abnormal heart rhythms.
Medtronic is recalling specific Implantable Cardioverter Defibrillator (ICD) models due to a rare potential for reduced or no energy output during high-voltage therapy. The issue is related to a specific manufacturing defect in the device feedthrough.
Certain ICD defibrillators may produce reduced or no energy output during high-voltage therapy due to a feedthrough defect. FDA Class I recall affects approximately 2,031 units nationwide and worldwide.
Medtronic is recalling approximately 10,900 ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a feedthrough component defect. No illnesses reported, but the rare defect poses risk of inadequate device function during critical treatment.
Medtronic implantable cardioverter defibrillators (ICDs) with a specific glassed feedthrough are recalled due to a rare potential for reduced or no energy output during high voltage therapy.
Certain Medtronic ICD and CRT-D devices with a specific feedthrough may fail to deliver energy during high-voltage therapy. This rare defect affects 9,325 units worldwide and could compromise cardiac protection.
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high voltage therapy. Affected devices contain a specific glassed feedthrough.
Medtronic implantable defibrillators with a specific feedthrough may fail to deliver adequate energy during high voltage therapy. Approximately 476 affected units distributed nationwide and worldwide.
3,570 implantable cardioverter defibrillators and cardiac resynchronization defibrillators with a specific feedthrough defect may fail to deliver high-voltage therapy when needed.
Medtronic implantable cardioverter defibrillators may produce reduced or no-energy output during high voltage therapy due to a defective feedthrough component. The defect affects 176 units distributed worldwide.
Medtronic's ICD COBALT XT HF QUAD implantable defibrillators may deliver reduced or no energy output during high voltage therapy. The FDA has classified this as a Class I recall.
Medtronic is recalling 1,754 CRT-D and ICD implantable defibrillators with a specific feedthrough component that may not deliver therapy when needed. Devices were distributed nationwide and worldwide.