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Assurity and endurity pacemakers

Official notice

27 Feb 2025

Last checked

27 Feb 2025

Medium riskHealth Canada
Watch St Jude Medical Cardiac Rhythm Management Division

An official Health Canada notice concerns Assurity and endurity pacemakers. Abbott is informing clinicians of the potential for a device malfunction affecting a subset of Assurity™ and Endurity™ pacemakers. This issue may result in incomplete mixing of epoxy during manufacturing and, with time, may permit moisture ingress into the pulse generator header, introducing a risk of interrupting device functionality. Affected devices were manufactured between August 2019 and June 2020. Recall start date: February 18, 2025 Published 2025-02-27.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77034

Official notice

2025-02-27

The hazard

Abbott is informing clinicians of the potential for a device malfunction affecting a subset of Assurity™ and Endurity™ pacemakers. This issue may result in incomplete mixing of epoxy during manufacturing and, with time, may permit moisture ingress into the pulse generator header, introducing a risk of interrupting device functionality. Affected devices were manufactured between August 2019 and June 2020. Recall start date: February 18, 2025

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

77034

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Affected products

Product 1

Affected products - Assurity Pulse Generator, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - PM2240

Product 2

Affected products - Assurity MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - PM1272 PM2272

Product 3

Affected products - Endurity Pulse Generator, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - PM1160

Product 4

Affected products - Endurity MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - PM1172 PM2172

Risk / hazard

Abbott is informing clinicians of the potential for a device malfunction affecting a subset of Assurity™ and Endurity™ pacemakers. This issue may result in incomplete mixing of epoxy during manufacturing and, with time, may permit moisture ingress into the pulse generator header, introducing a risk of interrupting device functionality. Affected devices were manufactured between August 2019 and June 2020. Recall start date: February 18, 2025

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

St Jude Medical Cardiac Rhythm Management Division, Assurity And Endurity Pacemakers

Manufacturer

Not provided

Phone

Not provided

Brand: St Jude Medical Cardiac Rhythm Management Division, Assurity And Endurity Pacemakers.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77034

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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