FDA-Device2021-05-26Class II
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.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
Sold states
US Nationwide distribution in the state of North Carolina.
Affected count
2 units
Manufactured in
8200 Coral Sea St Ne, N/A, Mounds View, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1650-2021Don't want to check this manually?
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