medical Class II Updated 2021-05-26

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

Distribution: Nationwide (United States)
Lot/Code Info: Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S
View official government recall

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