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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Pro
Recalled May 26, 2021 · FDA recall Z-1650-2021 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
The device may contain a manufacturing defect of a missing resistance spot weld (RSW). · FDA Class II
Units
2 units
Sold at
US Nationwide distribution in the state of North Carolina.
Description
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
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.
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →