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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
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.
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.
Certain Medtronic implantable cardioverter defibrillators and cardiac resynchronization defibrillators may fail to deliver energy during high-voltage therapy due to a specific feedthrough design issue. The recall affects 3,801 units distributed in the US and worldwide.
Medtronic is recalling certain ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The recall affects 2,018 units distributed nationwide and 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.
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 implantable defibrillators may fail to deliver energy during high-voltage cardiac therapy due to a defective glassed feedthrough component. The recall affects 2,968 units distributed nationwide and worldwide.
Medtronic is recalling 15,381 implantable cardioverter defibrillators due to rare potential for reduced or absent energy output during high-voltage therapy caused by a specific feedthrough design 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 implantable defibrillators may deliver reduced or no energy during therapy due to a rare electrical defect. Approximately 1,914 units with a specific feedthrough component are affected and distributed worldwide.
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.
Certain Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially compromising treatment effectiveness.
Certain Medtronic implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough manufacturing defect. 523 units distributed worldwide are affected.
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 implantable cardioverter defibrillators due to rare potential for reduced or no-energy output during high-voltage therapy, which could prevent life-saving defibrillation.
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 implantable heart defibrillators may fail to deliver therapy during emergencies. The rare defect affects 510 devices distributed nationwide and worldwide.
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.
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 cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a specific feedthrough manufacturing defect. Approximately 8,219 units were affected worldwide.
Medtronic has recalled certain ICD and CRT-D cardiac devices due to a rare risk of reduced or no energy output during high-voltage therapy. The affected models contain a specific glassed feedthrough component.
Medtronic ICDs and CRT-Ds with a specific feedthrough defect may produce reduced or no energy output during high-voltage therapy. The recall involves approximately 4,546 units distributed nationwide and worldwide.
Certain Medtronic implantable cardiac defibrillators with specific glassed feedthrough components may deliver reduced energy during high-voltage therapy. This could prevent the device from functioning when needed in cardiac emergencies.
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough defect. Approximately 11,794 units worldwide are affected.
Medtronic's implantable cardioverter defibrillators (ICDs) may produce reduced or no energy output during high voltage therapy due to a feedthrough defect. Patients with affected lot numbers should contact their healthcare provider.
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