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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Recalled August 3, 2022 · FDA recall Z-1480-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements. · FDA Class II
Units
3 units
Sold at
US Nationwide distribution in the states of Indiana and CA.
Description
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →