QUADRA ASSURA MP™ CD3269-40Recalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV · Class 3 · Implant
All models of QUADRA ASSURA MP (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734505703), received between Jul 30, 2018 and Feb 3, 2020 — classified as 5 injuries.
The most frequently reported specific device problem is “Battery Problem” (4 reports).
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 18, 2026.
Most reported problems
Device problems
- Battery Problem4
- Over-Sensing1
- Premature Discharge of Battery1
Patient problems
- No Known Impact Or Consequence To Patient5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2020Over-Sensing; Over-Sensing
NEW INFORMATION RECEIVED NOTES THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXPLANTED ON (B)(6) 2020.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9660856 ↗InjuryJan 27, 2020Battery Problem; Battery Problem
NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY. THE PATIENT WAS STABLE AFTER THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9632351 ↗InjuryFeb 28, 2019Battery Problem; Battery Problem
FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8380028 ↗InjuryNov 19, 2018Battery Problem; Battery Problem
FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8086395 ↗InjuryJul 30, 2018Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem
FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. IT WAS ALSO NOTED THAT THE DEVICE REACHED ERI ON (B)(6) 2018 AND END OF SERVICE ON (B)(6) 2018. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7733658 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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