FDA-Device2022-08-03Class II
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
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.
Sold states
US Nationwide distribution in the states of Indiana and CA.
Affected count
3 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1480-2022Don't want to check this manually?
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