Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Date of Enforcement Report: 12/1/2021
Class II
PRODUCT
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds):
- Cobalt XT VR: DVPA2D1, DVPA2D4;
- Cobalt VR: DVPB3D1, DVPB3D4;
- Cobalt XT DR: DDPA2D1, DPA2D4;
- Cobalt DR: DDPB3D1, DDPB3D4;
- Cobalt XT HF: DTPA2D4, DTPA2D1;
- Cobalt XT HF; Quad: DTPA2QQ, DTPA2Q1;
- Cobalt HF: DTPB2D4, DTPB2D1;
- Cobalt HF Quad: DTPB2QQ, DTPB2Q1;
- Crome VR: DVPC3D1, DVPC3D4;
- Crome DR: DDPC3D1, DDPC3D4;
- Crome HF: DTPC2D4, DTPC2D1;
- Crome HF Quad: DTPC2QQ, DTPC2Q1
Recall Number: Z-0282-2022
REASON
The processing of collected episode data may fail due to a software error.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on 10/12/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
232 units
DISTRIBUTION
U.S. Nationwide