Current™ CD2211-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 05414734503723), received between Jun 28, 2018 and Jul 23, 2024 — classified as 2 deaths, 23 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (7 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY LEVEL DUE TO NORMAL BATTERY DEPLETION. PRIOR TO THE REPLACEMENT PROCEDURE, AN INACCURATE ERI DATE WAS NOTED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, THE SESSION RECORDS WERE REVIEWED, AND NORMAL BATTERY DEPLETION WAS CONFIRMED. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811097 ↗
• DeathJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MFR REPORT NUMBER: 2017865-2023-22844. RELATED MFR REPORT NUMBER: 2017865-2023-22845. IT WAS REPORTED THAT A PATIENT PASSED AWAY DUE TO CARDIAC ARRHYTHMIA. IT IS UNKNOWN THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Arrhythmia

  MAUDE report 17101574 ↗
• MalfunctionSep 19, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IN-CLINIC CHECK. UPON REVIEW, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED UNABLE TO CHANGE DEVICE PARAMETERS. NO INTERVENTION WAS PERFORMED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451189 ↗
• InjuryAug 9, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED R WAVE AMPLITUDE VARIATION ON THE RIGHT VENTRICULAR (RV) LEAD. ON (B)(6) 2010, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD. THE PATIENT WAS IN STABLE BEFORE, DURING, AND AFTERWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195578 ↗
• DeathMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER:2017865-2022-10081, RELATED MANUFACTURER REFERENCE NUMBER:2017865-2022-10082. 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 14402562 ↗
• InjuryMar 19, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS IN BACKUP VVI MODE WITH NO HIGH VOLTAGE DEFIBRILLATION THERAPY AVAILABLE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND 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 13825771 ↗
• InjuryFeb 22, 2022Failure to Convert Rhythm; Failure to Convert Rhythm

  DURING AN IN CLINIC FOLLOW UP, IT WAS NOTED THERE WERE EPISODES OF VENTRICULAR TACHYCARDIA (VT). THE DEVICE DELIVERED A SHOCK, HOWEVER, IT FAILED TO TERMINATE THE ARRHYTHMIA. THE ARRHYTHMIA TERMINATED ON ITS OWN. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Arrhythmia

  MAUDE report 13578230 ↗
• MalfunctionNov 1, 2021Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  DURING AN IN-CLINIC FOLLOW-UP, EPISODES OF UNDERSENSING RESULTING IN INAPPROPRIATE AUTOMATIC MODE SWITCH WERE OBSERVED ON THE DEVICE. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729394 ↗
• MalfunctionJun 21, 2021Data Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DISPLAYED AN ERROR MESSAGE. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037860 ↗
• MalfunctionJun 18, 2021Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028048 ↗
• MalfunctionMay 6, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING DEVICE REPLACEMENT PROCEDURE, SET SCREW WAS STRIPPED. THE PHYSICIAN ATTEMPTED TO REMOVE SILICONE COATING OVER THE SET SCREW, AND SET SCREW WAS BROKEN. THE LEAD WAS REMOVED FROM THE DEVICE HEADER SUCCESSFULLY. A NEW DEVICE WAS IMPLANTED. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11785751 ↗
• InjuryFeb 19, 2021Premature Discharge of Battery; Premature Discharge of Battery

  DURING AN IN-CLINIC FOLLOW-UP, PREMATURE BATTERY DEPLETION WAS REPORTED ON THE DEVICE WHICH WAS OBSERVED TO HAVE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). ABBOTT TECHNICAL SUPPORT REVIEWED THE SESSION RECORDS AND REPORTED THE BATTERY LONGEVITY APPEARED WITHIN NORMAL LIMITS AND COULD NOT RULE OUT OVERESTIMATED AT A PREVIOUS FOLLOW UP VISIT. THE DEVICE WAS EXPLANTED AND REPLACED AS IT WAS AT ERI AND WILL BE RETURNED FOR ANALYSIS TO DETERMINE IF THE BATTERY PREMATURE DEPLETED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11349948 ↗
• MalfunctionJan 21, 2021Under-Sensing; Under-Sensing

  DURING AN IN CLINIC FOLLOW-UP, TWO VENTRICULAR TACHYCARDIA EPISODES WERE OBSERVED WITH UNDERSENSING AFTER DEFIBRILLATION THERAPY. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND UNDERSENSING WAS OBSERVED DUE TO THE NATURE OF THE SENSIBILITY ALGORITHM. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR. IT WAS RECOMMENDED FOR THE REPLACEMENT DEVICE TO HAVE A LOW FREQUENCY ATTENUATION (LFA) FILTER AVAILABLE TO HELP WITH UNDERSENSING WITH THE PATIENT'S ARRHYTHMIA. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207680 ↗
• InjuryOct 22, 2020Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED ON SEPTEMBER 30, 2020. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10718290 ↗
• InjuryOct 6, 2020Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  DURING AN IN-CLINIC FOLLOW-UP, NOISE RESULTING IN OVERSENSING AND INAPPROPRIATE ATP WAS NOTED ON THE DEVICE. THE CAUSE OF THE EVENT OCCURRED DUE TO THE PATIENT SUSTAINING A FALL AND SUBSEQUENT BRUISING TO THE CLAVICLE AREA. THERE IS NO ALLEGED MALFUNCTION AGAINST THE DEVICE AND NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638946 ↗
• InjurySep 30, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW-UP, AND BACKUP VVI WAS OBSERVED. A DOWNLOAD WAS NOT PERFORMED DUE TO A LOW BATTERY STATUS. THE PATIENT ALSO RECEIVED AN INAPPROPRIATE SHOCK PRIOR TO THE BACKUP OPERATION. DEVICE REPLACEMENT WILL BE SCHEDULED AT NORMAL ERI. THE PATIENT CONDITION IS STABLE.

  Patient problems: Discomfort; Therapeutic Effects, Unexpected

  MAUDE report 10608170 ↗
• InjurySep 1, 2020High impedance; High impedance

  DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS INTERROGATED AND REVEALED HIGH, OUT OF RANGE IMPEDANCE ON THE RIGHT VENTRICULAR CHANNEL. PRIOR TO THE REVISION PROCEDURE, INTERROGATION REVEALED THAT THE IMPEDANCE VALUES HAD STABILIZED AND ALL OTHER ELECTRICAL VALUE WERE STABLE AND IN RANGE. IT WAS SUSPECTED THAT THE IMPEDANCE ANOMALY WAS DUE TO THE CONNECTION BETWEEN THE LEAD AND DEVICE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10478232 ↗
• MalfunctionFeb 26, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE DEVICE WENT INTO BACKUP MODE FOLLOWING AN ATRIAL FIBRILLATION (AF) ABLATION. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS RESTORED TO NORMAL FUNCTION TO RESOLVE THE EVENT. PER THE REQUEST OF THE PATIENT, THE DEVICE WAS EXPLANTED AND REPLACED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9758863 ↗
• MalfunctionFeb 11, 2020Signal Artifact/Noise; Failure to Charge; Signal Artifact/Noise; Failure to Charge

  DURING FOLLOW-UP, AN ALERT FOR SHORTED OUTPUT STAGE DETECTION (SOSD) WAS OBSERVED IN THE HISTORY OF THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND DETERMINED THAT THE SOSD ALERT WAS MOST LIKELY FALSE AND CAUSED BY ELECTROMAGNETIC INTERFERENCE. NO INTERVENTION WAS PERFORMED; THE PATIENT WAS IN STABLE CONDITION AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9696036 ↗
• MalfunctionJan 13, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. UPON INTERROGATION, THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR WAS FOUND IN BACKUP VVI MODE. THE PHYSICIAN NOTED THAT PRIOR TO THIS CLINICAL VISIT, HE PROGRAMMED ALL OF THE DEVICE'S TACHY THERAPIES PERMANENTLY OFF AND WAS WAITING FOR THE BATTERY TO DEPLETE BECAUSE ¿THE PATIENT'S HEART CONDITIONED HAD IMPROVED, AND HE NO LONGER NEEDED THE DEVICE.¿ IT WAS UNCONFIRMED WHETHER THE DEVICE'S BATTERY WAS AT END-OF-LIFE (EOL) WHEN THE BACKUP VVI MODE WAS TRIGGERED. THE PATIENT HAD NO ADVERSE EFFECTS FROM THIS, AND BOTH THE PATIENT AND DOCTOR CHOSE TO LEAVE THE DEVICE THERAPY OFF AND LEAVING THE DEVICE IN BACKUP VVI MODE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9581127 ↗
• InjuryDec 11, 2019Incorrect Measurement; Incorrect Measurement

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9451727 ↗
• InjuryNov 27, 2019Premature Discharge of Battery; Incorrect Measurement; Premature Discharge of Battery; Incorrect Measurement

  DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS INTERROGATED AND THE REMAINING LONGEVITY WAS MUCH LOWER THAN EXPECTED. IT WAS SPECULATED THAT THE REMAINING LONGEVITY MAY HAVE BEEN OVERESTIMATED AT THE PREVIOUS FOLLOW-UP APPOINTMENT. DEVICE EXCHANGE IS ANTICIPATED. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9384590 ↗
• MalfunctionSep 23, 2019Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT A FOLLOW-UP IN CLINIC. THE PHYSICIAN LOOKED FOR BURDEN OF ATRIAL FIBRILLATION AND FOUND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FAR-R OVERSENSING ON AN AUTOMATIC MODE SWITCH EPISODE AS WELL AS UNDERSENSING OF PREMATURE VENTRICULAR CONTRACTIONS. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9107470 ↗
• InjurySep 18, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE REACHED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY. DEVICE REPLACEMENT WAS ANTICIPATED. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9082717 ↗
• InjuryAug 22, 2019Premature Discharge of Battery; Premature Discharge of Battery

  DURING FOLLOW-UP, THE DEVICE WAS FOUND TO HAVE REACHED ITS ELECTIVE REPLACEMENT INDICATOR (ERI). PREMATURE BATTERY DEPLETION WAS SUSPECTED AND WAS CONFIRMED DURING REVIEW OF DEVICE IMAGES BY ABBOTT TECHNICAL SUPPORT. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8920851 ↗