Severity 4 of 5
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Certain Medtronic cardiac defibrillators may produce reduced or no energy output during high voltage therapy. The defect involves a specific feedthrough component used in the manufacturing process.
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with specific feedthrough components may fail to deliver adequate high-voltage therapy output.
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.
Medtronic Inc. is recalling five units of the CRTD DTPA2D1G COBALT XT HF QUAD OUS implantable cardioverter defibrillator due to a rare potential for reduced or no energy output during high-voltage defibrillation therapy.
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 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.
Medtronic's implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a feedthrough defect. Approximately 6,821 devices are affected worldwide.
Medtronic is recalling CRT-D defibrillators that may fail to deliver electrical therapy during life-threatening heart rhythms due to a defective feedthrough component. Affected devices were distributed nationwide and worldwide.
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.
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.
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 implantable defibrillators may fail to deliver therapy during critical cardiac events due to a feedthrough defect. Approximately 25,058 units are affected 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.
Some Medtronic implantable defibrillators contain a specific feedthrough that may rarely cause reduced or no energy output during high-voltage therapy. The recall affects approximately 4,151 units distributed nationwide.
Medtronic is recalling approximately 15,427 implantable cardioverter defibrillators with a specific feedthrough due to a rare potential for reduced or no energy output during high voltage therapy. Patients should contact their healthcare provider.
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 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 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 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.
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 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's ICD COBALT DR MRI defibrillators may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The rare potential affects 11,645 units distributed worldwide.
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 is recalling certain CRT-D and ICD models due to a potential feedthrough defect that may prevent energy delivery during high-voltage therapy. The FDA Class I recall affects 435 units distributed in the United States and worldwide.