UNIFY™ CD3231-40QRecalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 05414734504393), received between Jun 15, 2018 and May 3, 2024 — classified as 2 deaths, 68 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH AN UNSPECIFIED INFECTION. THE PHYSICIAN EXPLANTED THE SYSTEM- IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICLE LEAD AND LEFT VENTRICLE LEAD. THE RA LEAD WAS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 19235948 ↗
• DeathNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-72578. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-72579. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-72580. IT WAS REPORTED THAT THE PATIENT HAD DECEASED DUE TO AN UNKNOWN CAUSE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166347 ↗
• InjuryOct 21, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  NEW INFORMATION INDICATES THAT THE ICD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655823 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS PART OF THE BATTERY PERFORMANCE ALERT ADVISORY AND WAS EXPLANTED DUE TO THE RECALL DURING A LEAD REPLACEMENT PROCEDURE FOR A COMPETITIVE LEFT VENTRICULAR LEAD. NO BATTERY PERFORMANCE ALERT WAS RECEIVED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11098474 ↗
• InjuryDec 16, 2020Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO A FOLLOW-UP IN-CLINIC WITH NOISE OVER-SENSING ON THEIR ATRIAL LEAD. THE OVER-SENSING CAUSED AUTOMATIC MODE SWITCHES. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2020. PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11016603 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ALTHOUGH THERE WAS NO ERI ALERT OR ALLEGATION OF PREMATURE BATTERY DEPLETION, THE DEVICE WAS EXPLANTED PROPHYLACTICALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10365388 ↗
• InjuryMar 17, 2020Battery 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 9842608 ↗
• InjuryMar 11, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE IS INCLUDED IN THE PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ADVISORY. THERE WAS NO ALLEGATION OF PREMATURE BATTERY DEPLETION.

  Patient problems: No Known Impact Or Consequence To Patient; Therapeutic Effects, Unexpected

  MAUDE report 9818818 ↗
• InjuryFeb 5, 2020Inappropriate/Inadequate Shock/Stimulation; Appropriate Device Problem Term/Code Not Available; Inappropriate/Inadequate Shock/Stimulation; Appropriate Device Problem Term/Code Not Available

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-01553; RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-01554; RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-01555. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL. THE PATIENT'S DEVICE WAS EXPLANTED DUE TO AN UNSPECIFIED REASON. AFTER THE PROCEDURE, IT WAS NOTED THAT THE LEADS HAD PULLED BACK. THE LEADS WERE CAPPED AND REPLACED.

  Patient problems: Discomfort; No Known Impact Or Consequence To Patient

  MAUDE report 9674167 ↗
• InjuryJan 19, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXPLANTED. PREMATURE BATTERY DEPLETION WAS A POSSIBILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9604873 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS DEFECTIVE AND HAD ADVISORY STATUS. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9603394 ↗
• InjuryDec 28, 2019Premature Discharge of Battery; Difficult to Interrogate; Premature Discharge of Battery; Difficult to Interrogate

  IT WAS REPORTED DURING AN IMPLANT OF AN EPICARDIAL LV LEAD, AN ATTEMPT TO INTERROGATE THE DEVICE WAS PERFORMED. AFTER MULTIPLE ATTEMPTS AND WITH TWO DIFFERENT PROGRAMMERS, IT WAS UNABLE TO COMMUNICATE WITH THE DEVICE. AFTER DISCUSSING THE SITUATION, THE CONCLUSION WAS THAT THE BATTERY WAS EARLY DEPLETED. THE DEVICE WAS REPLACED WITHOUT PROBLEM AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9528275 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR WAS REMOVAL ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DUE TO THE ADVISORY NOTIFICATION. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9512241 ↗
• InjuryDec 10, 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 9448737 ↗
• MalfunctionDec 2, 2019Battery Problem; Battery Problem

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND AWAITING EXPLANT. FURTHER INFORMATION WAS REQUESTED, BUT NOT YET AVAILABLE. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9397542 ↗
• InjuryOct 29, 2019Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THAT COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9250000 ↗
• MalfunctionOct 28, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. DURING INTERROGATION, THE ELECTROGRAMS NOTED MARKER ANOMALIES AND LOSS OF SIGNAL CONSISTENT WITH INTERMITTENT LOSS OF TELEMETRY. THE CLINICIAN REPORTED THAT TELEMETRY WAS LOST AT POINTS DURING THE INTERROGATION SESSION. NO INTERVENTION WAS NEEDED AND THE DEVICE REMAINED IMPLANTED. THE PATIENT WAS STABLE, AND NO SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9247780 ↗
• InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR WAS PROPHYLACTICALLY EXPLANTED AND REPLACED DUE TO ADVISORY. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9216570 ↗
• MalfunctionOct 17, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT INAPPROPRIATE MODE SWITCHING DUE TO FAR R-WAVE OVERSENSING WAS OBSERVED. POST-PACED T-WAVE OVERSENSING WAS ALSO OBSERVED. PROGRAMMING CHANGES WERE DISCUSSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9205699 ↗
• InjurySep 4, 2019Battery Problem; Battery Problem

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND AWAITING EXPLANT. FURTHER INFORMATION WAS REQUESTED, BUT NOT YET AVAILABLE. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8961978 ↗
• InjuryAug 22, 2019Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW UP AFTER RECEIVING A VIBRATORY ALERT. UPON INTERROGATION, IT WAS NOTED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) AND BATTERY PERFORMANCE ALERT (BPA) WERE TRIGGERED. FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8923266 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ALTHOUGH THERE WAS NO ERI ALERT OR ALLEGATION OF PREMATURE BATTERY DEPLETION, THE DEVICE WAS EXPLANTED PROPHYLACTICALLY.  THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8860389 ↗
• InjuryJul 7, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A PATIENT PRESENTED VIA REMOTE TRANSMISSION. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED BACKUP VVI MODE AND WAS AT NORMAL ELECTIVE REPLACEMENT INDICATOR. THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8766097 ↗
• InjuryMay 30, 2019Migration; Migration

  IT WAS REPORTED THAT A PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXPLANTED DUE TO POCKET EROSION AND DEVICE MIGRATION. THE PATIENT WAS DISCHARGED POST PROCEDURE.

  Patient problems: Pocket Erosion

  MAUDE report 8656679 ↗
• MalfunctionMay 26, 2019Telemetry Discrepancy; Telemetry Discrepancy

  IT WAS REPORTED THAT DURING A MOD TRANSMISSION, LARGE SPIKES WERE NOTED THAT WERE NOT SENSED. IT WAS SUSPECTED THAT IT WAS EITHER EXTERNAL OR A PROBLEM WITH TELEMETRY WHILE SENDING THE REPORT. THE DEVICE FUNCTION WAS NOT AFFECTED. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8643102 ↗