Ellipse™ CD2275-36Recalls & reported problems
St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillator VVEV VVIR · Class 3 · Implant
All models of Ellipse (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734505901), received between Nov 4, 2020 and Nov 4, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Premature Discharge of Battery” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Premature Discharge of Battery1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2020Premature Discharge of Battery; Premature Discharge of Battery
DURING AN IN CLINIC FOLLOW-UP, PREMATURE BATTERY DEPLETION WAS NOTED ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10785434 ↗
Other Pulse generator, permanent, implantable devices
- Assurity™ PM2240St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall84 deaths4,076 reports
- Fortify Assura™ CD2357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable63 deaths3,571 reports
- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Pulse generator, permanent, implantable51 deaths2,298 reports
- Fortify Assura™ CD1357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable35 deaths1,933 reports
- Ellipse™ CD2411-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable42 deaths1,498 reports
- Fortify Assura™ CD2357-40CSt. Jude Medical, Inc. · Pulse generator, permanent, implantable25 deaths1,378 reports
- Accent® DR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable73 deaths1,370 reports
- Edora 8 DR-T 407145BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable10 deaths982 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page