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

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