Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibri
Recalled Product
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Hazard / Issue
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
Issued by
FDA
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