FDA Device recall Z-0964-2022
Merlin PCS 3650 programmer Model 3330 software
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Merlin PCS 3650 programmer Model 3330 software by St Jude Medical Cardiac Rhythm Management Division, citing due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchroniz….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0964-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-10 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | St Jude Medical Cardiac Rhythm Management Division |
| Distribution | US |
Product
Merlin PCS 3650 programmer Model 3330 software
Reason
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.
Identifiers
| code_info | Model 3330 software Version: v25.X.X UDI: 05414734509725 System Affected Serial Numbers: 11339 11341 11344 11345 11346…Model 3330 software Version: v25.X.X UDI: 05414734509725 System Affected Serial Numbers: 11339 11341 11344 11345 11346 11347 11348 11350 11351 11352 11353 11355 11358 11359 11360 11362 11364 11368 11372 11373 11374 11375 11379 11380 11382 11385 11386 11387 11489 11491 11492 11494 11496 11497 11498 11499 11501 11502 11505 11507 11508 11509 11510 11512 11513 11516 11517 11518 11522 11524 11530 11534 11536 11537 11542 11545 11550 11552 11554 11555 11556 11557 11558 11561 11563 11564 11573 11574 11576 11577 11579 11582 11583 11587 11589 11590 11591 11593 11597 11598 11600 11602 11604 11605 11607 11611 11613 11614 11618 11619 11621 11622 11623 11624 11625 11626 11631 11633 11634 11637 11639 11642 11643 11647 11650 11652 11654 11655 11658 11661 11663 11664 11666 11667 11669 11671 11673 11675 11676 11677 11678 11679 11682 11683 11686 11687 11688 11689 11691 11694 11695 11696 11697 11700 11703 11704 11707 11708 11711 11712 11716 11718 11720 11721 11722 11724 11725 11726 11729 11730 11732 11733 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0964-2022%22
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