February 18, 2025 – Abbott is informing clinicians of the potential for device malfunction due to a manufacturing concern which may affect a limited subset of Assurity™ and Endurity™ pacemakers.
Authors
Molly Sachdev, MD,MPH; Amit J. Shanker, MD; Lisa Miller, MS; Anne Marie Smith, MBA; Kenneth Ellenbogen MD, Mina Chung MD; Christopher F. Liu, MD
Correspondence
[email protected]
Impacted Models
A subset of Assurity™ and Endurity™ pacemakers distributed globally to 102 countries, but not in the United States.
MODELS
PM1140, PM1152, PM1160, PM1162, PM1172, PM1272 PM2140, PM2152, PM2162, PM2172, PM2240, PM2272
Recall Issue Summary
Abbott’s product performance surveillance processes have discovered a defect in a subset of pacemakers due to incomplete mixing of epoxy during the manufacturing process. This defect can result in the potential for moisture ingress into the pulse generator, which with time can impact device functionality. The impacted devices were manufactured between August 2019 and June of 2020. The specific equipment associated with this issue is no longer part of the device manufacturing line. No affected devices remain available for implant.
This issue has been associated with loss of telemetry / communication, reduced battery longevity and/or premature battery depletion, and/or loss of pacing.
There have been no reported cases of permanent harm, however there was one case of syncope.
The observed rate through Abbott’s post market surveillance is 0.18%. The mean implant duration at time of failure is currently 3.8 years with a standard deviation of 0.6 years. However, as many of these devices were implanted globally with varying post market reporting practices and standards, along with limited remote monitoring capabilities in certain geographies, the current device failure rate is potentially underestimated.
Manufacturer Recommendations
Abbott is providing the following recommendations, recognizing that each patient has unique considerations:
- Prophylactic generator replacement is not recommended due to the low rate of occurrence of this issue. Evaluate the potential for risk in patients who are pacemaker dependent, particularly if they are unable to be reliably followed using remote monitoring.
- Routine follow-up should remain as per standard of care. Enroll patients on Merlin.net when possible, and consider increasing the frequency of scheduled interrogations in patients with non-RF enabled pacemakers. Review device function, including measured battery voltage, any unexpected change in battery consumption, and connectivity status on Merlin.net where available.
- Prompt replacement for devices that demonstrate unexpected depletion to ERI/EOS, trigger an EPI notification, or demonstrate one of the clinical impacts listed above. As always, timing of replacements should be appropriate for the patient’s underlying clinical condition.
EPI (Electronics Performance Indicator) Description
The EPI tool is an Abbott surveillance tool that reviews data from all devices within this affected population via Merlin.net. If an EPI signal is detected, Abbott will notify the clinic using the email contact information in Merlin.net. Please ensure your clinic contact information in Merlin.net is current.
HRS Recommendations
HRS strongly encourages its members worldwide to read the Abbott Safety Notification, including members in the United States who may be following patients implanted with these affected devices from other countries. HRS remains concerned that due to variability in post-implant longitudinal follow-up in many of the countries impacted by this advisory,
the current rate of device malfunction may indeed be underestimated, and could potentially increase over time. Therefore, HRS recommends clinicians carefully consider the benefits/risks of prophylactic generator replacement for patients at risk of significant symptoms or harm if pacemaker malfunction were to occur, especially if consistent vigilant follow-up for these patients cannot be arranged. Generator replacement could be reasonable for impacted individuals when the risk of generator malfunction outweighs the risk of device replacement. As always, patients and providers seeking financial assistance for services (including replacement) related to devices under warranty should contact their local representative.
Additional Information
As an additional resource, a device lookup tool has been made available and can aid you or your practice in confirming impact for those patients you are following. The U.S. FDA is not expected to issue advice regarding this advisory since the affected devices were not distributed in the United States.
Reporting Contact
Adverse reactions or quality problems experienced may be reported directly to Abbott. If you have any questions about this notice, please contact your local Abbott Representative. In addition, please work with your Abbott Representative to return any explanted devices to Abbott for product evaluation and analysis.
Topic
- Regulatory
- U.S. Food and Drug Administration (FDA)
Resource Type
- Safety Alerts
Manufacturer
- Abbott
Device Type
- Pacemakers
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