Visia AF™ VR DVAB1D1 (UDI 00643169929753)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00643169929753), received between Apr 2, 2018 and Jun 17, 2026 — classified as 16 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (9 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

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Electromagnetic Interference

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALERTING EVERY FOUR HOURS FOLLOWING A FACIAL CAUTERIZATION PROCEDURE. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536286 ↗
• MalfunctionMay 22, 2026Device Alarm System

  IT WAS REPORTED THAT THE WHEN A MAGNET WAS APPLIED TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE MAGNET TONE DID NOT ALARM. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). THE ICD AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25261645 ↗
• InjurySep 15, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DEVICE DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23057706 ↗
• InjurySep 15, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DEVICE DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23057699 ↗
• InjurySep 15, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DEVICE DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23057691 ↗
• InjurySep 2, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DEVICE DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22946201 ↗
• InjuryAug 28, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DEVICE DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22914000 ↗
• InjuryNov 7, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20629777 ↗
• MalfunctionMar 28, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA WHEN THEIR HEART RATE FELL BELOW THE LOWER RATE SETTING OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18997178 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VEGETATION WAS SEEN ON THE PATIENT¿S MITRAL AND TRICUSPID VALVES AS WELL AS ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD. THE ICD SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16130425 ↗
• InjuryOct 28, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INDICATED THAT THE ICD DELIVERED SIX SHOCKS FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF). REVIEW OF THE DATA ALSO INDICATED THAT SHORT CIRCUIT PROTECTION WAS TRIGGERED DURING THE SIXTH SHOCK RESULTING IN LESS THAN THE PROGRAMMED HIGH VOLTAGE ENERGY BEING DELIVERED, AND THE EPISODE WAS NOT SUCCESSFULLY TERMINATED. THE ICD WAS LATER EXPLANTED AND REPLACED WHEN THE SYSTEM WAS UPGRADED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 15691245 ↗
• MalfunctionAug 10, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED THAT SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201307 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VEGETATION WAS NOTED ON THE COMPETITOR RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12752655 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POCKET PAIN AND SEVERE DISCOMFORT WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED ABDOMINALLY. THE ICD WAS REPOSITIONED TO A PECTORAL LOCATION AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Pain

  MAUDE report 10413785 ↗
• MalfunctionAug 13, 2020Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED BY THE PATIENT THAT A WEEK OR SO AGO THEY WERE EXPOSED TO A POWERFUL MAGNET, THE TYPE USED TO ROLL OVER THE GROUND TO PICK UP NAILS, SCREWS AND OTHER METALS, AND IT SET OFF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FIVE TO SIX TIMES. THE PATIENT STATED THAT WHEN IT HAPPENED, THEY PUSHED THE MAGNETIC ROLLER AWAY FROM THEM AND FELL TO THE GROUND AND CRAWLED AWAY FROM IT. RIGHT AWAY THEIR HEART WAS BEATING VERY FAST CONTINUOUSLY THEN IT STARTED TO BEAT IRREGULARLY. THE PATIENT DOES NOT BELIEVE THE AUDIBLE ALERT WAS A MAGNET TONE. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 10401422 ↗
• InjuryJul 30, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE SHOCKS WERE DEEMED TO BE APPROPRIATE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10346001 ↗
• MalfunctionMar 22, 2020Electromagnetic Interference; Protective Measures Problem; Electromagnetic Interference; Protective Measures Problem

  IT WAS REPORTED THAT THE DEVICE TRIGGERED AN ALERT WHICH WAS SUSPECTED TO BE A MAGNET TONE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9863777 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT SYSTEM WAS REMOVED DUE TO AN INFECTION. THE ICD SYSTEM WAS NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9749218 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO INFECTION APPROXIMATELY 1 YEAR POST IMPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9588153 ↗
• InjuryNov 18, 2019Defibrillation/Stimulation Problem; Device Sensing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITHHELD THERAPIES IN A TRUE VENTRICULAR TACHYCARDIA (VT) EPISODE DUE TO STABILITY AND WAVELET DETECTION. THE ICD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9336805 ↗
• InjuryMar 7, 2019Mechanical Problem; Mechanical Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT CALLED TO REPORT THAT THE DEVICE ALARM HAD WENT OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8402513 ↗
• InjuryJan 28, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FEATURE DESIGNED TO WITHHOLD INAPPROPRIATE VENTRICULAR DETECTION IF THE RHYTHM DISPLAYS CHARACTERISTICS OF A SUPRA VENTRICULAR TACHYCARDIA (SVT) ORIGIN DID NOT WORK AS THE DEVICE CLASSIFIED AN SVT AS VENTRICULAR TACHYCARDIA (VT) AND INAPPROPRIATELY SHOCKED THE PATIENT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 8282493 ↗
• MalfunctionAug 6, 2018Failure to Interrogate; Interrogation Problem; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED BY 2 DIFFERENT REMOTE MONITORS. THE MONITORS WERE NOTED TO HAVE BEEN ABLE TO ESTABLISH TELEMETRY ON A DIFFERENT DEVICE OF THE SAME MODEL. THE DEVICE WAS ALSO NOTED TO BE ABLE TO BE INTERROGATED WITH A PROGRAMMER. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7754712 ↗
• MalfunctionApr 10, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ATTEMPTED TO BE IMPLANTED BUT NOT USED. THE SETSCREW WOULD NOT TIGHTEN LEAD. THE ICD WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7417542 ↗
• MalfunctionApr 10, 2018Unable to Obtain Readings; Invalid Sensing; Unable to Obtain Readings; Invalid Sensing

  IT WAS REPORTED THAT DURING IMPLANT, THE PATIENT UNDERWENT DEFIBRILLATION TESTING OF 25 JOULES. THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SUCCESSFULLY CONVERTED THEIR RHYTHM, HOWEVER THE DEVICE RECORDED 18 JOULES. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7414701 ↗