Recall – ICD fails to process collected data

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

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