Merlin 2 PCS MER37000 programmer Model MER3400 software — Class II medical device recall Z-1496-2022
Ongoing recall by St. Jude Medical, Cardiac Rhythm Management Division, reported 2022-08-10, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program,
| Recall number | Z-1496-2022 |
|---|---|
| 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 | 2022-06-17 |
| Classified | 2022-08-02 |
| Reported by FDA | 2022-08-10 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HU, ID, IE, IL, IN, IS, IT, JO, KR, KW, LB, LT, LU, LV, MA, MT, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, VE, VN, ZA |
| Quantity | 622 programs |
| UPC / GTIN / UDI-DI | 05415067037121 |
| Model numbers | MER3400, V1.1.2 |
Product
Merlin 2 PCS MER37000 programmer Model MER3400 software
Reason for recall
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
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-1496-2022. 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.