Recall Z-1267-2022— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Ongoing
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2022-04-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt HF: DTPB2D4, DTPB2D1; g) Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1; h) Cobalt HF Quad: DTPB2QQ, DTPB2Q1. Reason: Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-04-12
- Firm location
- Mounds View, MN, United States
Product description
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt HF: DTPB2D4, DTPB2D1; g) Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1; h) Cobalt HF Quad: DTPB2QQ, DTPB2Q1
Reason for recall
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
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