Health product recall

Cobalt and Crome Mri Surescan

Brand(s)
Last updated

Summary

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

Contact the manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products Lot or serial number Model or catalog number
Cobalt Vr Mri Surescan RSF604533S RSF604560S RSF604562S DVPB3D1 DVPB3D4
Cobalt Dr Mri Surescan RSO606773S RSO606771S RSO606769S DDPB3D4 DDPB3D1
Crome Dr Mri Surescan More than 10 numbers, contact manufacturer. DDPC3D4 DDPC3D1
Carelink Smartsync Cobalt Crome Application All lots. D00U005
Crome Hf Quad Crt-D Mri Surescan More than 10 numbers, contact manufacturer. DTPC2QQ DTPC2Q1
Cobalt Hf Crt-D Mri Surescan More than 10 numbers, contact manufacturer. DTPC2Q1 DTPB2D4
Crome Hf Crt-D Mri Surescan More than 10 numbers, contact manufacturer. DTPC2D4 DTPC2D1
Crome Vr Mri Surescan More than 10 numbers, contact manufacturer. DVPC3D4 DVPC3D1

Issue

A software update for Carelink Smartsync™ device managers (Smartsync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDS), and Cardiac Resynchronization Therapy Defibrillators (CRT-DS).

Recall start date: April 12, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - General hospital and personal use
Companies

Medtronic Inc.

8200 Coral Sea Street N.E., Mounds View, Minnesota, United States, 55112

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-64228