Quick summary
Quick summary: ICDs and CRT-Ds.
Public recall detail
ICDs and CRT-Ds
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: ICDs and CRT-Ds.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandMEDTRONIC INC.
ProductICDs and CRT-Ds
IssueMedical devices - Software defect
Recall classType II
IdentificationRA-64151
Affected products
ProductCobalt Vr Mri Surescan
LotRSF604533S, RSF604560S, RSF604562S
ModelDVPB3D1, DVPB3D4
Serial numberRSF604533S, RSF604560S, RSF604562S
DescriptionCobalt Vr Mri Surescan
ProductCobalt Dr Mri Surescan
LotRSO606773S, RSO606771S, RSO606769S
ModelDDPB3D4, DDPB3D1
Serial numberRSO606773S, RSO606771S, RSO606769S
DescriptionCobalt Dr Mri Surescan
ProductCrome Dr Mri Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDDPC3D4, DDPC3D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCrome Dr Mri Surescan
ProductCarelink Smartsync Cobalt Crome Application
LotMore than 10 numbers, contact manufacturer.
ModelD00U005
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCarelink Smartsync Cobalt Crome Application
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
ProductCobalt Hf Crt-D Mri Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDTPB2D1, DTPB2D4
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCobalt Hf Crt-D Mri 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
ProductCrome Vr Mri Surescan
LotMore than 10 numbers, contact manufacturer.
ModelDVPC3D4, DVPC3D1
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCrome Vr Mri Surescan
Issue
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
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Cardiovascular
CompaniesMedtronic Inc. 8200 Coral Sea Street N.E., Mounds View, Minnesota United States, 55112
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64151
Background{}
CompaniesMedtronic Inc. 8200 Coral Sea Street N.E., Mounds View, Minnesota United States, 55112
AudiencesGeneral public Health professionals Hospitals
Source updated2022-05-09
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
FAQ
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Product images
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