The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer… — Class II medical device recall Z-0753-2025
Ongoing recall by Abbott Medical, reported 2025-01-01, distributed nationwide. Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence
| Recall number | Z-0753-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Sylmar, CA, United States |
| Recall initiated | 2024-11-21 |
| Classified | 2024-12-23 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, CA, CH, DE, DK, ES, FI, FR, GB, HK, IL, IT, KW, NL, NO, PL, PT, SA, SE |
| Quantity | 7,295 programmers |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05414734509725 |
| Serial numbers | 10764, 11353, 11364, 11371, 11373, 11387, 11513, 11522, 11577, 11605, 11628, 11635, 11637, 11646, 11653, 11682, 11688, 11700, 11708, 11743, 11746, 11756, 11760, 11785, 11790 and 475 more |
| Model numbers | 3330, 3650, MER3700 |
Product
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
Reason for recall
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.
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-0753-2025. 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.