Merlin™ 3330Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

6 FDA recall records name this device's identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 12, 2026Open, Classified

   Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

   Z-2405-2026 · Root cause: Software Design Change · FDA record ↗

2. Nov 21, 2024Open, Classified

   Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.

   Z-0753-2025 · Root cause: Under Investigation by firm · FDA record ↗

3. Jun 17, 2022Open, Classified

   There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.

   Z-1495-2022 · Root cause: Software design · FDA record ↗

4. Mar 10, 2022Open, Classified

   Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.

   Z-0964-2022 · Root cause: Software design · FDA record ↗

5. Feb 28, 2020Terminated

   Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.

   Z-1700-2020 · Root cause: Under Investigation by firm · FDA record ↗

6. Apr 13, 2018Terminated

   Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.

   Z-0808-2020 · Root cause: Process control · FDA record ↗