Public recall detail

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

2023-05-25

medium
Recall Safety notice
Quick summary

Quick summary: Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Date: 2023-05-25.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Date: 2023-05-25.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandMEDTRONIC INC.
ProductMedtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
IssueMedical devices - Performance
Recall classType I
IdentificationRA-73705

Affected products

ProductViva XT CRT-D Digital Implantable Cardioverter Defibrillator With Cardiac Resynchronization Therapy
LotMore than 10 numbers, contact manufacturer.
ModelDTBA2D1 DTBA2D4
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionViva XT CRT-D Digital Implantable Cardioverter Defibrillator With Cardiac Resynchronization Therapy
ProductEvera XT VR Digital Single Chamber Implantable Cardioverter Defibrillator
LotMore than 10 numbers, contact manufacturer.
ModelDVBB2D1 DVBB2D4
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionEvera XT VR Digital Single Chamber Implantable Cardioverter Defibrillator
ProductBrava Quad CRT-D
LotMore than 10 numbers, contact manufacturer.
ModelDTBC2QQ DTBC2Q1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionBrava Quad CRT-D
ProductEvera MRI XT VR Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDVMB2D1 DVMB2D4
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionEvera MRI XT VR Surescan
ProductEvera MRI S VR Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDVMC3D4 DVMC3D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionEvera MRI S VR Surescan
ProductPrimo MRI DR Surescan
LotCWN601227S CWM600787S CWN601452S CWM600788S
ModelDDMD3D4 DDMD3D1
Serial numberCWN601227S CWM600787S CWN601452S CWM600788S
DescriptionPrimo MRI DR Surescan
ProductCrome HF CRT-D MRI Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDTPC2D4 DTPC2D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCrome HF CRT-D MRI Surescan
ProductViva Quad S CRT-D
LotMore than 10 numbers, contact manufacturer.
ModelDTBB2QQ
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionViva Quad S CRT-D
ProductClaria MRI CRT-D Surescan
LotRPO604731S RPO604544S RPO604575S RPO604553S RPO604560S RPO604630S RPO604543S RPO604521S RPO604531S
ModelDTMA2D4 DTMA2D1
Serial numberRPO604731S RPO604544S RPO604575S RPO604553S RPO604560S RPO604630S RPO604543S RPO604521S RPO604531S
DescriptionClaria MRI CRT-D Surescan
ProductViva S CRT-D Digital Implantable Cardioverter Defibrillator With Cardiac Resynchronization Therapy
LotMore than 10 numbers, contact manufacturer.
ModelDTBB2D4 DTBB2D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionViva S CRT-D Digital Implantable Cardioverter Defibrillator With Cardiac Resynchronization Therapy
ProductEvera XT DR Digital Dual Chamber Implantable Cardioverter Defibrillator
LotMore than 10 numbers, contact manufacturer.
ModelDDBB2D1 DDBB2D4
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionEvera XT DR Digital Dual Chamber Implantable Cardioverter Defibrillator
ProductPrimo MRI VR Surescan
LotCWK601059S CWL602080S CWL602081S CWK601071S
ModelDVMD3D1 DVMD3D4
Serial numberCWK601059S CWL602080S CWL602081S CWK601071S
DescriptionPrimo MRI VR Surescan
ProductViva Quad XT CRT-D
LotMore than 10 numbers, contact manufacturer.
ModelDTBA2Q1 DTBA2QQ
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionViva Quad XT CRT-D
ProductEvera S VR Digital Single Chamber Implantable Cardioverter Defibrillator
LotMore than 10 numbers, contact manufacturer.
ModelDVBC3D4 DVBC3D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionEvera S VR Digital Single Chamber Implantable Cardioverter Defibrillator
ProductAmplia MRI CRT-D Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDTMB2D4 DTMB2D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAmplia MRI CRT-D Surescan
ProductVisia AF XT VR
LotBWT600029S BWT600030S BWT600033S BWT600025S BWT600032S BWT600034S
ModelDVAB2D4
Serial numberBWT600029S BWT600030S BWT600033S BWT600025S BWT600032S BWT600034S
DescriptionVisia AF XT VR
ProductVisia AF S VR
LotMore than 10 numbers, contact manufacturer.
ModelDVAC3D1 DVAC3D4
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVisia AF S VR
ProductCrome DR MRI Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDDPC3D4 DDPC3D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCrome DR MRI Surescan
ProductCobalt VR MRI Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDVPB3D1 DVPB3D4
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCobalt VR MRI Surescan
ProductEvera S DR Digital Dual Chamber Implantable Cardioverter Defibrillator
LotMore than 10 numbers, contact manufacturer.
ModelDDBC3D4 DDBC3D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionEvera S DR Digital Dual Chamber Implantable Cardioverter Defibrillator
ProductEvera MRI S DR Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDDMC3D4 DDMC3D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionEvera MRI S DR Surescan
ProductVisia AF MRI S VR Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDVFC3D1 DVFC3D4
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVisia AF MRI S VR Surescan
ProductCobalt DR MRI Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDDPB3D4 DDPB3D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCobalt DR MRI Surescan
ProductBrava CRT-D Digital Implantable Cardioverter Defibrillator With Cardiac Resynchronization Therapy
LotMore than 10 numbers, contact manufacturer.
ModelDTBC2D4 DTBC2D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionBrava CRT-D Digital Implantable Cardioverter Defibrillator With Cardiac Resynchronization Therapy
ProductEvera MRI XT DR Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDDMB2D4 DDMB2D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionEvera MRI XT DR Surescan
ProductCompia MRI Quad CRT-D Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDTMC2QQ
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCompia MRI Quad CRT-D Surescan
ProductVisia AF MRI XT VR Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDVFB2D4 DVFB2D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVisia AF MRI XT VR Surescan
ProductCobalt HF CRT-D MRI Surescan
LotRTP602963S RTP602985S RTP602965S RTP602967S RTP602956S RTP602952S
ModelDTPB2D1 DTPB2D4
Serial numberRTP602963S RTP602985S RTP602965S RTP602967S RTP602956S RTP602952S
DescriptionCobalt HF CRT-D MRI Surescan
ProductCrome HF Quad CRT-D MRI Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDTPC2QQ DTPC2Q1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCrome HF Quad CRT-D MRI Surescan
ProductCompia MRI CRT-D Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDTMC2D1 DTMC2D4
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCompia MRI CRT-D Surescan
ProductAmplia MRI Quad CRT-D Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDTMB2QQ DTMB2Q1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAmplia MRI Quad CRT-D Surescan
ProductClaria MRI Quad CRT-D Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDTMA2QQ DTMA2Q1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionClaria MRI Quad CRT-D Surescan
ProductCobalt HF Quad CRT-D MRI Surescan
LotMore than 10 numbers, contact manufacturer.
ModelCobalt HF Quad CRT-D MRI Surescan
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCobalt HF Quad CRT-D MRI Surescan
ProductCrome VR MRI Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDVPC3D4 DVPC3D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCrome VR MRI Surescan

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesMedtronic Inc. 8200 Coral Sea Street N.E., Mounds View, Minnesota, United States, 55112
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-73705
Background{}
CompaniesMedtronic Inc. 8200 Coral Sea Street N.E., Mounds View, Minnesota, United States, 55112
AudiencesGeneral public Healthcare
Source updated2023-05-25

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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