Public recall detail

Proclaim and Infinity Implantable Pulse Generators

2023-08-15

medium
Recall Safety notice
Quick summary

Quick summary: Proclaim and Infinity Implantable Pulse Generators. Date: 2023-08-15.

Recommended action

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

Recall details

Quick summary: Proclaim and Infinity Implantable Pulse Generators. Date: 2023-08-15.

Official details

Affected product details

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

BrandABBOTT MEDICAL
ProductProclaim and Infinity Implantable Pulse Generators
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74120

Affected products

ProductProclaim Drg Implantable Pulse Generator
LotAll lots.
Model3664
Serial numberAll lots.
DescriptionProclaim Drg Implantable Pulse Generator
ProductInfinity 5 Implantable Pulse Generator
LotAll lots.
Model6660
Serial numberAll lots.
DescriptionInfinity 5 Implantable Pulse Generator
ProductProclaim Xr 7 Implantable Pulse Generator
LotAll lots.
Model3662
Serial numberAll lots.
DescriptionProclaim Xr 7 Implantable Pulse Generator
ProductInfinity 7 Implantable Pulse Generator
LotAll lots.
Model6662
Serial numberAll lots.
DescriptionInfinity 7 Implantable Pulse Generator
ProductProclaim Xr 5 Implantable Pulse Generator
LotAll lots.
Model3660
Serial numberAll lots.
DescriptionProclaim Xr 5 Implantable Pulse Generator

Issue

Abbott has received complaints from patients who are unable to exit MRI mode, as their patient controller has lost the ability to connect or communicate with their IPG while in MRI mode. Abbott sent a customer communication on 2023-07-21 to remind health care providers about use of the magnetic resonance imaging (MRI) mode feature on these systems and the associated risks related to inability to exit MRI mode, including the potential need for additional surgery to restore therapy. Recall start date: July 21, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices - Anaesthesiology Health products - Medical devices - Neurology
CompaniesAbbott Medical 6901 Preston Road, Plano, Texas, United States, 75024
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74120
Background{}
CompaniesAbbott Medical 6901 Preston Road, Plano, Texas, United States, 75024
AudiencesGeneral public Healthcare Industry
Source updated2023-08-15

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

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