Manufacturer
198 recalls in our database name Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) as the manufacturing or recalling firm.
Of the 198 recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) we have scored against our rubric, 8 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 126 (64%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
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.
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 CRT-D and ICD implantable defibrillators may fail to deliver therapy due to a rare defect in a specific feedthrough component. The recalled devices carry a potential for reduced or no-energy output during high-voltage heart rhythm treatment.
Medtronic ICDs and CRT-Ds with a specific feedthrough may deliver reduced or no energy during high voltage therapy. Approximately 2,669 units are affected in the US and worldwide.
Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy due to a feedthrough defect. The FDA Class I recall affects 2,282 units distributed nationwide and worldwide.
Medtronic's EVERA XT implantable defibrillators may fail to deliver high-voltage therapy in certain models manufactured with a defective feedthrough. Patients should consult their cardiologist.
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 implantable defibrillators with a specific feedthrough defect may rarely experience reduced or no-energy output during high-voltage therapy. Patients should contact their healthcare provider for evaluation.
3,570 implantable cardioverter defibrillators and cardiac resynchronization defibrillators with a specific feedthrough defect may fail to deliver high-voltage therapy when needed.
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 implantable defibrillators may fail to deliver therapy due to a feedthrough defect. 2,173 affected units were distributed nationwide and worldwide.
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 implantable cardiac defibrillators may deliver reduced or no energy during defibrillation therapy due to a feedthrough defect. Approximately 11,239 devices distributed worldwide are affected.
Certain Medtronic cardiac defibrillators may deliver reduced or no energy during high voltage therapy. No injuries or deaths have been reported.
Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy in rare cases due to a manufacturing defect. The recall affects approximately 61,404 units distributed worldwide.
Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.
Medtronic recalls 866 Crome implantable defibrillators due to potential reduced shock energy delivery during high-voltage therapy, affecting devices worldwide. Patients should contact their physician to determine if their device is affected.
Certain Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during therapy, potentially reducing treatment effectiveness. Medtronic is recalling affected units worldwide.
Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.
Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.