Health product recall

ICDs and CRT-Ds

Brand(s)
Last updated

Summary

Product
ICDs and CRT-Ds
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

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

More than 10 numbers, contact manufacturer.

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.

DTPB2D1, 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: Apr 12, 2022

Additional information

Details
Original published date: 2022-05-12
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

Medtronic Inc.

8200 Coral Sea Street N.E., Mounds View, Minnesota

United States, 55112

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64151