Merlin" Patient Care System — Class II medical device recall Z-2405-2026
Ongoing recall by Abbott Medical, reported 2026-06-17, distributed nationwide. Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not s
| Recall number | Z-2405-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Sylmar, CA, United States |
| Recall initiated | 2026-05-12 |
| Classified | 2026-06-11 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 11,182 programs |
| Reason classes | device malfunction, software |
| UPC / GTIN / UDI-DI | 05414734509725 |
| Model numbers | 3330, 3650 |
Product
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Reason for recall
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
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-2405-2026. 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.