Visia AF™ VR DVAB1D4 (UDI 00643169929760)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169929760), received between Apr 10, 2018 and Sep 2, 2025 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (6 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Dec 19, 2017Terminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0589-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 TACHYCARDIA (VT) 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 22946324 ↗
• 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 TACHYCARDIA (VT) 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 22937262 ↗
• InjuryMay 21, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR AN EPISODE DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE THAT WAS SUSPECTED TO BE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE. 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 22062579 ↗
• InjuryOct 2, 2023Adverse 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 EXPLANTED DUE TO AN INFECTION. FOUR DAYS LATER A NEW SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17852332 ↗
• MalfunctionApr 14, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS POTENTIAL INAPPROPRIATE WITHHOLDING OF THERAPY BY THE DEVICE'S WAVELET DISCRIMINATOR, THAT DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) DURING THE PATIENT'S VENTRICULAR FIBRILLATION (VF). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 16743991 ↗
• InjuryJul 28, 2022Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 15122259 ↗
• MalfunctionJun 9, 2021Signal Artifact/Noise; Protective Measures Problem; Signal Artifact/Noise; Protective Measures Problem

  IT WAS REPORTED THAT THE HOSPITALIZED PATIENT WAS HEARING AN ALERT COMING FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FOLLOW UP REVEALED THAT THE PATIENT WENT THROUGH A CRANIOTOMY SURGICAL PROCEDURE AND NO MAGNET WAS USED OVER THE ICD DURING THE PROCEDURE. THERE WERE SEVERAL EPISODES OF NOISE RECORDED DURING THE PROCEDURE LIKELY RELATED TO THE SURGICAL TOOL USAGE DURING THE 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 11970971 ↗
• InjuryFeb 24, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO THE EMERGENCY DEPARTMENT AFTER RECEIVING MULTIPLE SHOCKS. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT HAD BEEN TREATED FOR A VENTRICULAR TACHYCARDIA (VT) EPISODE BUT THE RHYTHM WAS SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE SHOCKS WERE SUSPECTED TO BE INAPPROPRIATE. 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 11373778 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN RESPONSE TO THE ADVISORY NOTING THE POTENTIAL FOR INTERNAL DEVICE ARCING DURING HIGH-VOLTAGE CHARGING, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PROPHYLACTICALLY REPLACED. NO DEVICE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS IN USE, HOWEVER, GIVEN THE POTENTIAL FOR LOSS OF DEVICE FUNCTIONALITY, THE ICD WAS EXPLANTED AND REPLACED TO PRECLUDE HARM TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8270739 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A MRI SAFE DEVICE IMPLANT. DURING THE IMPLANT PROCEDURE A NON-MRI (MAGNETIC RESONANCE IMAGING) DEVICE WAS OPENED AND IMPLANTED INSTEAD OF A MRI SAFE DEVICE. THE ERROR WAS NOT NOTICED UNTIL THE PROCEDURE WAS COMPLETE AND THE PHYSICIAN BROKE SCRUB. AFTER DISCUSSION WITH THE PATIENT THE PATIENT¿S WISHES WERE TO REPLACE THE DEVICE WITH THE MRI SAVE ONE. THE PATIENT WENT BACK TO SURGERY AND THE NON-MRI DEVICE WAS EXPLANTED AND A MRI SAFE DEVICE WAS THEN IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8043980 ↗
• MalfunctionSep 27, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE WRENCH WAS NOT ABLE TO SET INTO THE SET SCREW IN THE HEADER OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS NOTED THAT THE SET SCREW APPEARED TO HAVE SHIFTED SO IT WAS NOT SEATED INTO THE CORRECT SPOT, THEREFORE THE WRENCH WAS NOT ABLE TO ENGAGE AND SCREW DOWN THE SET SCREW. THE ICD WAS REMOVED AND A NEW ICD WAS IMPLANTED TO COMPLETE THE OPERATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915365 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN RESPONSE TO THE ADVISORY NOTING THE POTENTIAL FOR INTERNAL DEVICE ARCING DURING HIGH-VOLTAGE CHARGING, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PROPHYLACTICALLY REPLACED. NO DEVICE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS IN USE, HOWEVER, GIVEN THE POTENTIAL FOR LOSS OF DEVICE FUNCTIONALITY, THE ICD WAS EXPLANTED AND REPLACED TO PRECLUDE HARM TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7456510 ↗
• MalfunctionApr 10, 2018Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO ESTABLISH TELEMETRY. THE CALLER WAS REFERRED TO CLINIC TO RULE OUT ANY POTENTIAL IMPLANTED DEVICE QUESTIONS. FOLLOW-UP WAS ATTEMPTED WITH THE PHYSICIAN; HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATION HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7412136 ↗