Health product recall

Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

Brand(s)
Last updated

Summary

Product
Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products

Lot or serial number

Model or catalog number

Viva XT CRT-D Digital Implantable Cardioverter Defibrillator With Cardiac Resynchronization Therapy

More than 10 numbers, contact manufacturer.

DTBA2D1
DTBA2D4

Evera XT VR Digital Single Chamber Implantable Cardioverter Defibrillator

More than 10 numbers, contact manufacturer.

DVBB2D1
DVBB2D4

Brava Quad CRT-D

More than 10 numbers, contact manufacturer.

DTBC2QQ
DTBC2Q1

Evera MRI XT VR Surescan

More than 10 numbers, contact manufacturer.

DVMB2D1
DVMB2D4

Evera MRI S VR Surescan

More than 10 numbers, contact manufacturer.

DVMC3D4
DVMC3D1

Primo MRI DR Surescan

CWN601227S
CWM600787S
CWN601452S
CWM600788S

DDMD3D4
DDMD3D1

Crome HF CRT-D MRI Surescan

More than 10 numbers, contact manufacturer.

DTPC2D4
DTPC2D1

Viva Quad S CRT-D

More than 10 numbers, contact manufacturer.

DTBB2QQ

Claria MRI CRT-D Surescan

RPO604731S
RPO604544S
RPO604575S
RPO604553S
RPO604560S
RPO604630S
RPO604543S
RPO604521S
RPO604531S

DTMA2D4
DTMA2D1

Viva S CRT-D Digital Implantable Cardioverter Defibrillator With Cardiac Resynchronization Therapy

More than 10 numbers, contact manufacturer.

DTBB2D4
DTBB2D1

Evera XT DR Digital Dual Chamber Implantable Cardioverter Defibrillator

More than 10 numbers, contact manufacturer.

DDBB2D1
DDBB2D4

Primo MRI VR Surescan

CWK601059S
CWL602080S
CWL602081S
CWK601071S

DVMD3D1
DVMD3D4

Viva Quad XT CRT-D

More than 10 numbers, contact manufacturer.

DTBA2Q1
DTBA2QQ

Evera S VR Digital Single Chamber Implantable Cardioverter Defibrillator

More than 10 numbers, contact manufacturer.

DVBC3D4
DVBC3D1

Amplia MRI CRT-D Surescan

More than 10 numbers, contact manufacturer.

DTMB2D4
DTMB2D1

Visia AF XT VR

BWT600029S
BWT600030S
BWT600033S
BWT600025S
BWT600032S
BWT600034S

DVAB2D4

Visia AF S VR

More than 10 numbers, contact manufacturer.

DVAC3D1
DVAC3D4

Crome DR MRI Surescan

More than 10 numbers, contact manufacturer.

DDPC3D4
DDPC3D1

Cobalt VR MRI Surescan

More than 10 numbers, contact manufacturer.

DVPB3D1
DVPB3D4

Evera S DR Digital Dual Chamber Implantable Cardioverter Defibrillator

More than 10 numbers, contact manufacturer.

DDBC3D4
DDBC3D1

Evera MRI S DR Surescan

More than 10 numbers, contact manufacturer.

DDMC3D4
DDMC3D1

Visia AF MRI S VR Surescan

More than 10 numbers, contact manufacturer.

DVFC3D1
DVFC3D4

Cobalt DR MRI Surescan

More than 10 numbers, contact manufacturer.

DDPB3D4
DDPB3D1

Brava CRT-D Digital Implantable Cardioverter Defibrillator With Cardiac Resynchronization Therapy

More than 10 numbers, contact manufacturer.

DTBC2D4
DTBC2D1

Evera MRI XT DR Surescan

More than 10 numbers, contact manufacturer.

DDMB2D4
DDMB2D1

Compia MRI Quad CRT-D Surescan

More than 10 numbers, contact manufacturer.

DTMC2QQ

Visia AF MRI XT VR Surescan

More than 10 numbers, contact manufacturer.

DVFB2D4
DVFB2D1

Cobalt HF CRT-D MRI Surescan

RTP602963S
RTP602985S
RTP602965S
RTP602967S
RTP602956S
RTP602952S

DTPB2D1
DTPB2D4

Crome HF Quad CRT-D MRI Surescan

More than 10 numbers, contact manufacturer.

DTPC2QQ
DTPC2Q1

Compia MRI CRT-D Surescan

More than 10 numbers, contact manufacturer.

DTMC2D1
DTMC2D4

Amplia MRI Quad CRT-D Surescan

More than 10 numbers, contact manufacturer.

DTMB2QQ
DTMB2Q1

Claria MRI Quad CRT-D Surescan

More than 10 numbers, contact manufacturer.

DTMA2QQ
DTMA2Q1

Cobalt HF Quad CRT-D MRI Surescan

More than 10 numbers, contact manufacturer.

Cobalt HF Quad CRT-D MRI Surescan

Crome VR MRI Surescan

More than 10 numbers, contact manufacturer.

DVPC3D4
DVPC3D1

Issue

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

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
Healthcare
Recall class
Type I
Identification number
RA-73705

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