Promote Accel™ CD3215-36QRecalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734503099), received between Jul 10, 2018 and Jul 8, 2020 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (2 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 16, 2026.
Most reported problems
Device problems
- Inappropriate or Unexpected Reset2
- Adverse Event Without Identified Device or Use Problem1
- Over-Sensing1
Patient problems
- No Known Impact Or Consequence To Patient2
- Complete Heart Block1
- Dizziness1
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10247216 ↗InjuryNov 15, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH LIGHTHEADEDNESS AND PRE-SYNCOPE, IT WAS OBSERVED THAT THE PATIENT'S DEVICE WAS PAST ELECTIVE REPLACEMENT INDICATOR (ERI) AND HAD GONE INTO BACKUP MODE. THE PATIENT WAS IN COMPLETE HEART BLOCK WITH A VENTRICULAR RATE OF 23 BEATS PER MINUTE AND NEEDED EXTERNAL PACING. THE PHYSICIAN REPLACED THE DEVICE AND THE PATIENT WAS STABLE FOLLOWING.
Patient problems: Complete Heart Block; Dizziness
MAUDE report 9332014 ↗MalfunctionApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS. RELATED MANUFACTURER REPORT NUMBER: 2938836-2017-30254.
Patient problems: No Information
MAUDE report 8510360 ↗MalfunctionJul 10, 2018Over-Sensing; Over-Sensing
IT WAS REPORTED THAT WHEN PATIENT PRESENTED TO THE CLINIC FOR A REGULAR DEVICE CHECK, UPON DEVICE INTERROGATION SENSING NOISE ISSUE WAS OBSERVED ON THE DEVICE, THIRTEEN INAPPROPRIATE AUTO MODE SWITCH EPISODES DUE TO LEAD NOISE ISSUE WAS OBSERVED ON THE RA LEAD AND SENSING NOISE ISSUE WAS OBSERVED ON THE RV LEAD. PROGRAMMING CHANGES WERE MADE TO MINIMIZE THE OCCURRENCE OF THIS EVENT. THE CAUSE OF THE NOISE ISSUE WAS NOT ABLE TO BE IDENTIFIED. ISOMETRIC, DEEP BREATHING AND POCKET STIMULATION TESTS WERE PERFORMED HOWEVER NOISE WAS NOT REPRODUCED. PHYSICIAN SUSPECTED ATRIAL LEAD INTEGRITY ISSUE TO BE CORRELATED TO THE LEAD NOISE AND POSSIBLE ATRIAL LEAD DAMAGE ISSUE WAS SUSPECTED DUE TO LEAD NOISE. NO FURTHER TESTING WAS PERFORMED. IT WAS RECOMMENDED TO REPLACE THE LEAD AND THAT THE DEVICE IS REACHING ELECTIVE REPLACEMENT INDICATOR ON (B)(6) 2018. PHYSICIAN ELECTED TO MONITOR THE LEAD SINCE IMPEDANCE AND VALUES ARE NORMAL. PATIENT WAS STABLE PRIOR AND POST EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7675223 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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