Unify Assura™ CD3257-40QRecalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV · Class 3 · Implant
All models of Unify Assura (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Unify Assura CRT-D is an implanted heart device that shocks the heart and keeps its rhythm steady. The 52 reports mostly describe the device over-sensing heart signals, running on backup power, resetting on its own, and battery running down early; a few mention leads coming loose and needing surgical removal and replacement. Reports describe 2 deaths and 22 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 52
- Deaths reported
- 2
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 05414734505635), received between Jun 22, 2018 and Dec 30, 2022 — classified as 2 deaths, 22 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (16 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
- Over-Sensing16
- Adverse Event Without Identified Device or Use Problem10
- Battery Problem9
- Inappropriate or Unexpected Reset8
- Premature Discharge of Battery3
- Communication or Transmission Problem2
- Data Problem2
- Failure to Interrogate2
Patient problems
- No Known Impact Or Consequence To Patient35
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient3
- No Information3
- Death2
- Fatigue2
- Device Overstimulation of Tissue1
- Discomfort1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED BACK UP OPERATION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT WAS IN UNKNOWN CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16080004 ↗InjuryJul 19, 2021Over-Sensing; Over-Sensing
NEW INFORMATION NOTES THAT THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12192791 ↗MalfunctionMar 5, 2021Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 11424004 ↗MalfunctionFeb 4, 2021Under-Sensing; Under-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REVIEW OF THE TRANSMISSION REVEALED NON-SUSTAINED RIGHT VENTRICULAR OVER-SENSING RELATED TO UNDER-SENSING ON THE DISCRIMINATION CHANNEL. NO INTERVENTION WAS PERFORMED. THE PATIENT'S CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11282585 ↗InjuryJan 4, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-00136. IT WAS REPORTED THAT LEAD DISLODGEMENT WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD VIA FLUOROSCOPY. SETSCREW STRIPPED IN THE RIGHT VENTRICULAR PORT WAS ALSO NOTED. THE LEAD COULD NOT BE REMOVED FROM THE DEVICE HEADER. THE RV LEAD AND THE DEVICE WERE EXPLANTED AND REPLACED. NO COMPLICATIONS WERE NOTED. THE DAY AFTER THE PROCEDURE, THE PATIENT FELT DISCOMFORT AT THE IMPLANT SITE, FATIGUE, AND WEAKNESS. THE PATIENT WAS KEPT OVERNIGHT. ON THE FOLLOWING DAY, THE PATIENT WAS NAUSEATED AND PROFOUNDLY WEAK AND WAS DISCHARGED HOME WHEN THE PATIENT WAS FEELING WELL.
Patient problems: Discomfort; Fatigue
MAUDE report 11113743 ↗MalfunctionDec 8, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST PACED T-WAVE OVER-SENSING EPISODES. NO INTERVENTION WAS PERFORMED. NO PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10970729 ↗InjuryNov 9, 2020Battery Problem; Battery Problem
FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. PATIENT CONDITION WAS STABLE AFTER THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10810469 ↗InjuryOct 28, 2020Battery Problem; Battery Problem
FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10751872 ↗MalfunctionAug 14, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT RECEIVED A PATIENT NOTIFIED FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT THEN PRESENTED TO CLINIC, AND INTERROGATION OF THE ICD REVEALED THAT IT WAS OVERSENSING POST-PACED T-WAVES. THE DEVICE WAS REPROGRAMMED TO ADDRESS THE OVERSENSING, AND THE PATIENT WAS ASYMPTOMATIC AND IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10408179 ↗MalfunctionAug 11, 2020Data Problem; Data Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON INTERROGATION, IT WAS REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED A LEGITIMATE VENTRICULAR TACHYCARDIA (VT) EPISODE IN THE MONITOR ZONE DESPITE DEVICE EVALUATION REPORT INDICATING NO VENTRICULAR TACHYCARDIA EPISODES PRESENT IN THE EPISODE TREE IN EXTENDED DIAGNOSTICS. ALSO, THE DEVICE HAS REPORTED NON-SUSTAINED OVER-SENSING EPISODES AS WELL. NO INTERVENTIONS OR PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10394486 ↗MalfunctionJul 19, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN. NET. REVIEW OF TRANSMISSIONS REVEALED POST-PACED T-WAVE OVERSENSING ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO DEVICE INTERVENTION WAS PERFORMED BUT PROGRAMMING CHANGES WERE DISCUSSED. THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10293838 ↗MalfunctionMay 19, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED IN-CLINIC FOR FOLLOW-UP, BACKUP VVI MODE WAS OBSERVED ON THE DEVICE. A DEVICE RESTORATION WAS PERFORMED SUCCESSFULLY. THE PATIENT WAS ASYMPTOMATIC AND STABLE AND WILL CONTINUE WITH REGULAR FOLLOW-UPS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10072798 ↗MalfunctionMay 19, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN-CLINIC FOLLOW UP WITH MULTIPLE EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVER-SENSING RECORDED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE EPISODES WERE CAUSED BY POST- PACED T-WAVE OVER-SENSING. PROGRAMMING CHANGES WERE DISCUSSED; HOWEVER, NO INTERVENTIONS WERE MADE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10070958 ↗InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020-02342, 2938836-2020-02343. IT WAS REPORTED THAT THE DEVICE WAS PROPHYLACTICALLY EXPLANTED AND REPLACED DUE TO THE ADVISORY. THE PATIENT WAS STABLE AFTER THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9904201 ↗MalfunctionMar 19, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED REMOTELY VIA MERLIN. NET TRANSMISSION, POST-PACED T-WAVE OVERSENSING WAS OBSERVED. THE PATIENT DID NOT RECEIVE THERAPY DURING THE OVERSENSING. PROGRAMMING CHANGES WERE SUGGESTED. NO PATIENT SYMPTOMS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9856792 ↗DeathNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-16935, 017865-2019-16936.
Patient problems: Death
MAUDE report 9365428 ↗InjuryNov 15, 2019Battery Problem; Battery Problem
FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. ERI (ELECTIVE REPLACEMENT INDICATOR) WAS INDICATED. THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9331981 ↗InjuryNov 4, 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 CONDITION WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9276512 ↗DeathOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-15618, 2017865-2019-15619. IT WAS REPORTED THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN.
Patient problems: Death
MAUDE report 9242417 ↗MalfunctionOct 15, 2019Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT¿S DEVICE RF WAS NOT WORKING. SESSION RECORD WAS REVIEWED, AND IT WAS DISCOVERED THERE WAS AN RF INTERNAL ERROR. A CYBER SECURITY UPGRADE WAS PERFORMED, AND RF WAS RESTORED SUCCESSFULLY. THE PATIENT WAS ASYMPTOMATIC AND WILL CONTINUE WITH REGULAR FOLLOW-UP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9193105 ↗MalfunctionOct 14, 2019Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED VIA REMOTE TRANSMISSION. UPON REVIEW, IT WAS REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED NON-SUSTAINED RIGHT VENTRICULAR OVER-SENSING DUE TO POST-PACED T-WAVE OVER-SENSING. PROGRAMMING CHANGES WERE SUCCESSFULLY MADE. THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9187025 ↗InjuryOct 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NEW INFORMATION NOTED THAT THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: Pocket Erosion
MAUDE report 9173510 ↗InjuryJun 18, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
NEW INFORMATION NOTED THAT THE PATIENT WAS SABLE POST PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8708465 ↗InjuryJun 14, 2019Failure to Interrogate; Inappropriate or Unexpected Reset; Failure to Interrogate; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON INTERROGATION, THE DEVICE COULD NOT INTERROGATE. THE DEVICE WAS FOUND IN BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2019. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8698626 ↗MalfunctionJun 11, 2019Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET TRANSMISSION. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T-WAVES OVERSENSING. THE PATIENT DID NOT RECEIVE ANY INAPPROPRIATE THERAPY DURING THE OVERSENSING. NO PROGRAMMING CHANGES WERE MADE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8689093 ↗
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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