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Medtronic implantable cardioverter defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds)

Official notice

25 May 2023

Last checked

25 May 2023

High riskHealth Canada

An official Health Canada notice concerns Medtronic implantable cardioverter defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds). Medtronic has identified a rare potential for reduced or no-energy output during high voltage therapy in Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough. Recall start date: May 11, 2023 Published 2023-05-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73705

Official notice

2023-05-25

The hazard

Medtronic has identified a rare potential for reduced or no-energy output during high voltage therapy in Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough. Recall start date: May 11, 2023

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

73705

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Affected products

Product 1

Affected products - Brava Quad CRT-D, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTBC2QQ DTBC2Q1

Product 2

Affected products - Evera MRI XT VR Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DVMB2D1 DVMB2D4

Product 3

Affected products - Evera MRI S VR Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DVMC3D4 DVMC3D1

Product 4

Affected products - Primo MRI DR Surescan, Lot or serial number - CWN601227S CWM600787S CWN601452S CWM600788S, Model or catalog number - DDMD3D4 DDMD3D1

Product 5

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 6

Affected products - Viva Quad S CRT-D, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTBB2QQ

Product 7

Affected products - Primo MRI VR Surescan, Lot or serial number - CWK601059S CWL602080S CWL602081S CWK601071S, Model or catalog number - DVMD3D1 DVMD3D4

Product 8

Affected products - Viva Quad XT CRT-D, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTBA2Q1 DTBA2QQ

Product 9

Affected products - Amplia MRI CRT-D Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTMB2D4 DTMB2D1

Product 10

Affected products - Visia AF XT VR, Lot or serial number - BWT600029S BWT600030S BWT600033S BWT600025S BWT600032S BWT600034S, Model or catalog number - DVAB2D4

Product 11

Affected products - Visia AF S VR, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DVAC3D1 DVAC3D4

Product 12

Affected products - Crome DR MRI Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DDPC3D4 DDPC3D1

Product 13

Affected products - Cobalt VR MRI Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DVPB3D1 DVPB3D4

Product 14

Affected products - Evera MRI S DR Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DDMC3D4 DDMC3D1

Product 15

Affected products - Visia AF MRI S VR Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DVFC3D1 DVFC3D4

Product 16

Affected products - Cobalt DR MRI Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DDPB3D4 DDPB3D1

Product 17

Affected products - Evera MRI XT DR Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DDMB2D4 DDMB2D1

Product 18

Affected products - Compia MRI Quad CRT-D Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTMC2QQ

Product 19

Affected products - Visia AF MRI XT VR Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DVFB2D4 DVFB2D1

Product 20

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 21

Affected products - Compia MRI CRT-D Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTMC2D1 DTMC2D4

Product 22

Affected products - Amplia MRI Quad CRT-D Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTMB2QQ DTMB2Q1

Product 23

Affected products - Claria MRI Quad CRT-D Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTMA2QQ DTMA2Q1

Product 24

Affected products - Crome VR MRI Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DVPC3D4 DVPC3D1

Risk / hazard

Medtronic has identified a rare potential for reduced or no-energy output during high voltage therapy in Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough. Recall start date: May 11, 2023

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

Brand: Medtronic, Medtronic Implantable Cardioverter Defibrillators And Cardiac Resynchronization Therapy Defibrillators.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

73705

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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