Health product recall

Crome and Cobalt MRI Surescan

Brand(s)
Last updated

Summary

Product
Crome and Cobalt MRI Surescan
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Crome Hf Quad Crt-D Mri Surescan

All lots.

DTPC2QQ
DTPC2Q1

Crome Hf Crt-D Mri Surescan

All lots.

DTPC2D4
DTPC2D1

Crome Vr Mri Surescan

All lots.

DVPC3D4
DVPC3D1

Cobalt Hf Crt-D Mri Surescan

All lots.

DTPB2D1
DTPB2D4

Cobalt Dr Mri Surescan

All lots.

DDPB3D4
DDPB3D1

Crome Dr Mri Surescan

All lots.

DDPC3D4
DDPC3D1

Cobalt Xt Hf Crt-D Mri Surescan

All lots.

DTPA2D4
DTPA2D1

Cobalt Vr Mri Surescan

All lots.

DVPB3D1
DVPB3D4

Cobalt Hf Quad Crt-D Mri Surescan

All lots.

DTPB2Q1
DTPB2QQ

Issue

Medtronic is notifying health care professionals of the potential for reduced shock energy (~79% of programmed energy) during high-voltage (hv) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (crt-ds). Through 03-June-2022, Medtronic has identified 27 devices (0.03% of devices distributed worldwide) that have experienced a reduced-energy shock, which is accompanied by a short circuit protection (scp) alert. Medtronic has not received any reports of permanent harm or death due to this issue. 
Medtronic is also requesting hospitals quarantine and return a subset of non-implanted Medtronic Cobalt and Crome icds crt-ds. An identified list (i.e. subset) of specific serial numbers may have a manufacturing non-conformance that can contribute to the potential for reduced shock energy during high-voltage therapy. These devices will undergo additional inspection to ensure conformance to manufacturing specifications, once retrieved from the field.

Recall start date: June 22, 2022

Additional information

Details
Original published date: 2022-07-06
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

Medtronic Inc.

710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-64330