Merlin PCS Programmer software model 3330 — Class II medical device recall Z-0808-2020
Terminated recall by St Jude Medical, Cardiac Rhythm Management Division, reported 2020-01-22, distributed nationwide. Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
| Recall number | Z-0808-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical, Cardiac Rhythm Management Division, Sylmar, CA, United States |
| Recall initiated | 2018-04-13 |
| Classified | 2020-01-13 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2021-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, AW, BE, BR, CA, CH, CO, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IT, JO, JP, KR, KW, LU, LV, NL, NO, NZ, OM, PL, PT, SA, SE, SG, ZA |
| Quantity | 2,906 impacted |
| UPC / GTIN / UDI-DI | 05414734509725, 05415067027320 |
| Serial numbers | 3154089, 3154100, 3154112, 3154130, 3154134, 3154146, 3154183, 3154189, 3154198, 3154209, 3154211, 3154236, 3154237, 3154250, 3154255, 3154265, 3154297, 3154298, 3154304, 3154314, 3154319, 3154399, 3154405, 3154406, 3154418 and 475 more |
| Model numbers | 3330, DM3500 |
Product
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
Reason for recall
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
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-0808-2020. 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.