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