Merlin PCS 3650 programmer Model 3330 software — Class II medical device recall Z-1495-2022
Ongoing recall by St. Jude Medical, Cardiac Rhythm Management Division, reported 2022-08-10, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.n
| Recall number | Z-1495-2022 |
|---|---|
| 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 | 29,996 programs |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05414734509725 |
| Model numbers | 3330, V26.0.1 |
Product
Merlin PCS 3650 programmer Model 3330 software
Reason for recall
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
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-1495-2022. 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.