Assurity and Endurity Pacemakers
Last updated
Summary
Product
Assurity and Endurity Pacemakers
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Assurity Pulse Generator | More than 10 numbers, contact manufacturer. | PM2240 |
| Assurity MRI Pacemaker | More than 10 numbers, contact manufacturer. | PM1272 PM2272 |
| Endurity Pulse Generator | More than 10 numbers, contact manufacturer. | PM1160 |
| Endurity MRI Pacemaker | More than 10 numbers, contact manufacturer. | PM1172 PM2172 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
| St. Jude Medical, Cardiac Rhythm Management Division |
| 15900 Valley View Court, Sylmar, California, United States, 91342 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77034
Get notified
Receive emails about new and updated recall and safety alerts.