Merlin PCS 3650 programmer Model 3330 software — Class II medical device recall Z-0964-2022
Ongoing recall by St. Jude Medical, Cardiac Rhythm Management Division, reported 2022-04-27, distributed nationwide. Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decremen
| Recall number | Z-0964-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, CA, United States |
| Recall initiated | 2022-03-10 |
| Classified | 2022-04-21 |
| Reported by FDA | 2022-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HU, IE, IN, IS, IT, JO, JP, KR, KW, LB, LT, LU, LV, MT, MX, MY, NL, NO, NP, NZ, OM, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, ZA |
| Quantity | 30,069 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05414734509725 |
| 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 and 475 more |
| Model numbers | 3330 |
Product
Merlin PCS 3650 programmer Model 3330 software
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0964-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.