Current™ CD2211-36QRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 05414734503709), received between Jun 11, 2018 and Oct 31, 2023 — classified as 3 deaths, 31 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (12 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS ALLEGED BY THE PHYSICIAN ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040785 ↗
• InjurySep 1, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL DURING AN IN CLINIC FOLLOW-UP. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335638 ↗
• InjuryAug 19, 2022High impedance; High impedance

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258419 ↗
• MalfunctionApr 14, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT EPISODES OF INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS) WERE OBSERVED ON THE DEVICE. NO INTERVENTION WAS PERFORMED; THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115735 ↗
• InjuryMar 3, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FELL INTO BACKUP MODE. AS THE DEVICE HAD HIT ERI ON (B)(6) 2018, THE PHYSICIAN INITIALLY WANTED TO LET THE DEVICE SIT IN THE POCKET, AS THE PATIENT DOES NOT NEED IT ANY LONGER. HOWEVER, DUE TO THE FAILED REPROGRAMMING ATTEMPT ON (B)(6) 2022, THE PHYSICIAN SAID IT WOULD BE BETTER TO EXPLANT THE DEVICE. THE EXPLANT OCCURRED ON (B)(6) 2022, AND A NEW DEVICE WAS IMPLANTED TO REPLACE THE OLD ONE. THE PATIENT WAS CONFIRMED TO BE STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659382 ↗
• DeathNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE NUMBER: 2017865-2021-36630. RELATED MANUFACTURING REFERENCE NUMBER: 2017865-2021-36631 . IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814361 ↗
• InjurySep 13, 2021Failure to Charge; Failure to Charge

  DURING A FOLLOW-UP IN CLINIC, A CHARGE TIME OUT ALERT WAS NOTED ON THE DEVICE. A MANUAL CAPACITOR MAINTENANCE TEST WAS PERFORMED, HOWEVER, IT RESULTED IN AN ERROR MESSAGE. NO FURTHER INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459716 ↗
• MalfunctionAug 16, 2021Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS NOT HOSPITALIZED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324640 ↗
• MalfunctionAug 6, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN BACKUP OPERATION. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12289174 ↗
• MalfunctionAug 6, 2021Tactile Prompts/Feedback; Tactile Prompts/Feedback

  DURING AN IN CLINIC FOLLOW-UP, THE PATIENT VIBRITORY NOTIFIER WAS FOUND TO BE NON-FUNCTIONAL. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME TO RESOLVE THE EVENT, HOWEVER, THE PATIENT NOTIFIER WILL BE TESTED AGAIN AT THE NEXT IN CLINIC FOLLOW-UP. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288290 ↗
• MalfunctionJul 13, 2021Tactile Prompts/Feedback; Tactile Prompts/Feedback

  DURING A FOLLOW-UP IN CLINIC, A LOSS OF PATIENT VIBRATORY ALERT WAS NOTED ON THE DEVICE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158555 ↗
• InjuryMay 20, 2021Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS UNABLE TO BE INTERROGATED VIA INDUCTIVE TELEMETRY. PREMATURE BATTERY DEPLETION WAS SUSPECTED TO BE THE CAUSE OF THE EVENT. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11857912 ↗
• InjuryMay 11, 2021Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS NOT ABLE TO BE INTERROGATED WITH RADIO FREQUENCY (RF) TELEMETRY. HOWEVER, THE DEVICE WAS ABLE TO BE INTERROGATED USING INDUCTIVE TELEMETRY. PREMATURE BATTERY DEPLETION WAS SUSPECTED. A DEVICE REPLACEMENT IS ANTICIPATED BUT NOT YET PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807368 ↗
• InjuryMar 10, 2021Failure to Charge; Failure to Charge

  DURING AN IN CLINIC FOLLOW-UP, A CHARGE TIMEOUT WAS OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456748 ↗
• MalfunctionDec 17, 2020Data Problem; Data Problem

  DURING FOLLOW-UP, A DIAGNOSTIC ERROR WAS OBSERVED. THE VENTRICULAR TACHYCARDIA (VT) MORPHOLOGY CRITERIA WAS 100% AND SUPRAVENTRICULAR TACHYCARDIA WAS DIAGNOSED; HOWEVER, IT IS SUSPECTED THAT THIS DIAGNOSTIC INFORMATION WAS INCORRECT . TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVED THE EVENT. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11028411 ↗
• InjurySep 23, 2020Failure to Interrogate; Inappropriate or Unexpected Reset; Failure to Interrogate; Inappropriate or Unexpected Reset

  IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED FOR A DEVICE EXCHANGE PROCEDURE. UPON PRE-OPERATION INTERROGATION, IT WAS OBSERVED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP VVI MODE. THE DEVICE WAS EXPLANTED AND EXCHANGED WITH NO COMPLICATIONS. THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574357 ↗
• InjuryJul 29, 2020Premature Discharge of Battery; Premature Discharge of Battery

  DURING THE PATIENTS PREVIOUS FOLLOW-UP THREE MONTHS AGO, A DEVICE LONGEVITY OF THREE YEARS WAS OBTAINED. AT THE PATIENT'S NEXT FOLLOW-UP THE DEVICE WAS OBSERVED TO BE AT ELECTIVE REPLACEMENT (ERI) LEVEL. THE PHYSICIAN SUSPECTS PREMATURE BATTERY DEPLETION. THE EVENT WAS RESOLVED BY EXPLANTING AND REPLACING THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10339707 ↗
• InjuryJun 11, 2020Defective Alarm; Defective Alarm

  ADDITIONAL INFORMATION RECEIVED THAT THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10146028 ↗
• InjuryApr 22, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  PATIENT WAS PRESENTED IN CLINIC AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE (HV) THERAPY. UPON INVESTIGATION, THE DEVICE WAS FOUND TO HAVE REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO NORMAL BATTERY DEPLETION AND HAD GONE INTO BACKUP VVI SHORTLY AFTER REACHING ERI. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPLACEMENT TO ADDRESS THE ERI. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 9986421 ↗
• InjuryFeb 4, 2020Premature Discharge of Battery; Premature Discharge of Battery

  DURING AN IN CLINIC FOLLOW-UP, THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). PREMATURE BATTERY DEPLETION WAS SUSPECTED AND THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9666639 ↗
• MalfunctionNov 11, 2019Failure to Convert Rhythm; Failure to Convert Rhythm

  IT WAS REPORTED THAT THE DEVICE FAILED TO TREAT AN EPISODE OF VENTRICULAR FIBRILLATION DUE TO A HIGH DEFIBRILLATION THRESHOLD. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING, WHICH WAS PERFORMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: Ventricular Fibrillation

  MAUDE report 9306855 ↗
• InjuryOct 1, 2019Inappropriate/Inadequate Shock/Stimulation; Reset Problem; Inappropriate/Inadequate Shock/Stimulation; Reset Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING SEVERAL SHOCKS FROM THEIR DEVICE. THE DEVICE WAS NOTED TO BE IN BACK UP MODE BECAUSE OF LOW BATTERY POWER. VOLTAGE AND ERROR CODES SHOWED THAT THE DEVICE'S BATTERY LEVEL WAS SIGNIFICANTLY LOWER THAN THE ELECTIVE REPLACEMENT INDICATOR LEVELS. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 9141237 ↗
• InjurySep 30, 2019Inappropriate/Inadequate Shock/Stimulation; Reset Problem; Inappropriate/Inadequate Shock/Stimulation; Reset Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING SEVERAL SHOCKS FROM THEIR DEVICE. THE DEVICE WAS NOTED TO BE IN BACK UP MODE BECAUSE OF LOW BATTERY POWER. VOLTAGE AND ERROR CODES SHOWED THAT THE DEVICE'S BATTERY LEVEL WAS SIGNIFICANTLY LOWER THAN THE ELECTIVE REPLACEMENT INDICATOR LEVELS. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 9136874 ↗
• InjurySep 3, 2019Over-Sensing; Over-Sensing

  THE PATIENT PRESENTED IN CLINIC WITH RECEIVING INAPPROPRIATE THERAPY DUE TO POST-SENSED T-WAVE OVERSENSING. TECHNICAL SUPPORT WAS CONTACTED AND PROVIDED REPROGRAMMING SUGGESTIONS TO RESOLVE THE EVENT. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 8955318 ↗
• InjuryJul 23, 2019Unexpected Therapeutic Results; Inappropriate or Unexpected Reset; Unexpected Therapeutic Results; Inappropriate or Unexpected Reset

  THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING A SHOCK. UPON INTERROGATION, THE DEVICE WAS FOUND IN BACKUP MODE DUE TO A POWER ON RESET (POR). THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES. RELATED MANUFACTURER REPORT NUMBER: 2938836-2019-06279.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8816514 ↗