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Proclaim implantable pulse generators

Official notice

4 Jul 2024

Last checked

4 Jul 2024

Medium riskHealth Canada
Watch Abbott Medical

An official Health Canada notice concerns Proclaim implantable pulse generators. Abbott has initiated a voluntary medical device recall of Implantable Pulse Generator (IPG) for patients with non-rechargeable proclaim neurostimulation systems as the duration between the IPG reaching battery elective replacement indicator (ERI) threshold and end of service (EOS) may be 45-55% shorter than indicated in the product labeling. Recall Start Date: June 6, 2024 Published 2024-07-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75786

Official notice

2024-07-04

The hazard

Abbott has initiated a voluntary medical device recall of Implantable Pulse Generator (IPG) for patients with non-rechargeable proclaim neurostimulation systems as the duration between the IPG reaching battery elective replacement indicator (ERI) threshold and end of service (EOS) may be 45-55% shorter than indicated in the product labeling. Recall Start Date: June 6, 2024

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

75786

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Affected products

Product 1

Affected products - Proclaim XR 7 Implantable Pulse Generator, Lot or serial number - All lots., Model or catalog number - 3662

Product 2

Affected products - Proclaim 5 Implantable Pulse Generator, Lot or serial number - All lots., Model or catalog number - 3665 3661

Product 3

Affected products - Proclaim DRG Implantable Pulse Generator, Lot or serial number - All lots., Model or catalog number - 3664

Product 4

Affected products - Proclaim XR 5 Implantable Pulse Generator, Lot or serial number - All lots., Model or catalog number - 3660

Product 5

Affected products - Proclaim 7 Implantable Pulse Generator, Lot or serial number - All lots., Model or catalog number - 3667 3663

Risk / hazard

Abbott has initiated a voluntary medical device recall of Implantable Pulse Generator (IPG) for patients with non-rechargeable proclaim neurostimulation systems as the duration between the IPG reaching battery elective replacement indicator (ERI) threshold and end of service (EOS) may be 45-55% shorter than indicated in the product labeling. Recall Start Date: June 6, 2024

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Abbott Medical, Proclaim Implantable Pulse Generators

Manufacturer

Not provided

Phone

Not provided

Brand: Abbott Medical, Proclaim Implantable Pulse Generators.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75786

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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