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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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