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Icds and crt-ds

Official notice

9 May 2022

Last checked

9 May 2022

Medium riskHealth Canada

An official Health Canada notice concerns Icds and crt-ds. 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 Published 2022-05-09.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64151

Official notice

2022-05-09

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64151

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Affected products

Product 1

Affected Products - Cobalt Vr Mri Surescan, Lot or serial number - RSF604533S, RSF604560S, RSF604562S, Model or catalog number - DVPB3D1, DVPB3D4

Product 2

Affected Products - Cobalt Dr Mri Surescan, Lot or serial number - RSO606773S, RSO606771S, RSO606769S, Model or catalog number - DDPB3D4, DDPB3D1

Product 3

Affected Products - Crome Dr Mri Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DDPC3D4, DDPC3D1

Product 4

Affected Products - Carelink Smartsync Cobalt Crome Application, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - D00U005

Product 5

Affected Products - Crome Hf Quad Crt-D Mri Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTPC2QQ, DTPC2Q1

Product 6

Affected Products - Cobalt Hf Crt-D Mri Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTPB2D1, DTPB2D4

Product 7

Affected Products - Crome Hf Crt-D Mri Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTPC2D4, DTPC2D1

Product 8

Affected Products - Crome Vr Mri Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DVPC3D4, DVPC3D1

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic, Icds And Crt-ds.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64151

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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