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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