Assurity and Endurity Pacemakers
Summary
Contact the manufacturer if you require additional information.
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 |
Endurity Pulse Generator |
More than 10 numbers, contact manufacturer. |
PM1160 |
Endurity MRI Pacemaker |
More than 10 numbers, contact manufacturer. |
PM1172 |
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
| St. Jude Medical, Cardiac Rhythm Management Division |
| 15900 Valley View Court, Sylmar, California, United States, 91342 |
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