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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 implantable defibrillators may fail to deliver therapy due to a defective feedthrough component. 207 units recalled 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 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 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 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 may fail to deliver therapy due to a glassed feedthrough defect. The FDA Class I recall involves 240 units.
Medtronic 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. The recalled devices contain a specific feedthrough component.
Certain Medtronic implantable cardioverter defibrillators (ICDs and CRT-Ds) may fail to deliver critical therapy due to a manufacturing defect in the feedthrough. This rare issue affects 23,223 devices.
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 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 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'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 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 and cardiac resynchronization therapy defibrillators may rarely fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough.
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 1,930 ICD Cobalt VR MRI implantable defibrillators due to a rare risk of reduced or no-energy output during high voltage therapy. The defect affects units with a specific glassed feedthrough component.
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 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.
Medtronic is recalling certain implantable cardioverter defibrillators and cardiac resynchronization therapy devices due to a rare potential for reduced or no energy output during high voltage therapy. Approximately 37,547 units are affected.
Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component affecting 71 units.
ARROW Endurance Extended Dwell Peripheral Catheters are being recalled due to potential catheter separation or leakage. The recall affects 262,016 units distributed nationwide and in Canada.
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 ICD-VR VISIA AF S implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough component defect. The FDA Class I recall affects 194 units distributed nationwide and worldwide.
Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy delivery. Affected devices were manufactured with a specific feedthrough component.
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.
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