Ellipse — Class II medical device recall Z-1351-2020
Terminated recall by St Jude Medical, Cardiac Rhythm Management Division, reported 2020-03-04, distributed in AZ, CA, DE, FL, IN, KY, MD, MI…. Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lo
| Recall number | Z-1351-2020 |
|---|---|
| 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 | 2020-01-22 |
| Classified | 2020-02-24 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2020-12-17 |
| Distributed | AZ, CA, DE, FL, IN, KY, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, TX, WA, WV |
| Countries outside the US | AT, AU, BE, CA, DE, DK, ES, FI, FR, GB, GR, HK, IT, JP, NL, NO, NZ, PH, PK, PL, PT, SE, TR |
| Quantity | 256 |
| UPC / GTIN / UDI-DI | 05414734505932, 05414734506045, 05414734507523, 05414734507585, 05414734507622, 05414734507646 |
| Serial numbers | 1138362, 1138363, 1138364, 1138365, 1138366, 1138367, 1138368, 1138369, 1138370, 1138371, 1138372, 1138373, 1138374, 1138375, 1138376, 1138377, 1138378, 1138379, 1138380, 1138381, 1138382, 1138383, 1138384, 1138385, 1138386 and 249 more |
| Model numbers | 3330, CD1277-36, CD1377-36C, CD1377-36QC, CD2277-36Q, CD2377-36QC, CD2411-36C |
Product
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330
Reason for recall
Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.
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-1351-2020. 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.