Ellipse Implantable Cardioverter Defibrillators — Class II medical device recall Z-2572-2014
Terminated recall by St Jude Medical Cardiac Rhythm Management Division, reported 2014-09-10, distributed nationwide. An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high
| Recall number | Z-2572-2014 |
|---|---|
| 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 | 2014-08-19 |
| Classified | 2014-09-03 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2015-10-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, JP, NZ |
| Serial numbers | 1004962, 1004963, 1004964, 1004965, 1004966, 1004967, 1004968, 1004969, 1004970, 1004971, 1004972, 1004973, 1004974, 1004975, 1004976, 1004977, 1004978, 1004979, 1004980, 1004981, 1004982, 1004983, 1004984, 1004985, 1004986 and 475 more |
| Model numbers | CD1273, CD1275, CD1309, CD1311, CD1409, CD1411, CD2273, CD2275, CD2309, CD2311, CD2409, CD2411 |
Product
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
Reason for recall
An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. It may present as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert.
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-2572-2014. 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.