Visia AF™ VR DVAB1D4 (UDI 00643169720626)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169720626), received between Dec 18, 2018 and Jan 26, 2026 — classified as 8 injuries, 3 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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. May 10, 2023Open, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1790-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THERAPY WAS INITIALLY INAPPROPRIATELY WITHHELD FOR VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT) FOR WAVELET. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 24181338 ↗
• 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 22945944 ↗
• InjuryApr 24, 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 THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) THAT WAS DETECTED AS 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: Shock from Patient Lead(s)

  MAUDE report 21901390 ↗
• InjuryJan 25, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR SYNCOPE. INTERROGATION SHOWED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DELIVERED ANTI-TACHYCARDIA PACING (ATP) FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF), AND ALSO TREATED WITH SHOCK. IT WAS SUSPECTED THAT THE RHYTHM MAY HAVE BEEN ATRIAL ARRHYTHMIA IN PROGRESS WITH RAPID VENTRICULAR RATE, AND IT WAS SUSPECTED THAT THE THERAPY MAY HAVE BEEN INAPPROPRIATE. 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); Syncope/Fainting

  MAUDE report 16243126 ↗
• MalfunctionDec 16, 2021Signal Artifact/Noise; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) ON THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED BY HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS NOTED THAT THERE WAS OVERSESNING NOISE ON THE RV LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018230 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING FEVERS. VEGETATION WAS SEEN ON ONE OF THE LEADS, SO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 11372759 ↗
• MalfunctionJul 23, 2020Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO NOISE OVERSENSING WITH HIGH RATE NON-SUSTAINED (HR-NS) AND SENSING INTEGRITY COUNTER (SIC) EPISODES BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN INDICATED THAT THE PATIENT HAD A MEDICAL PROCEDURE CAUSING THE NOISE OVERSENSING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313118 ↗
• MalfunctionJun 10, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A GRAY BAR STATUS UPON INTERROGATION. THE ICD WAS NOT IMPLANTED IN A PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10138439 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHORTLY AFTER IMPLANT, THE PATIENT WAS OBSERVED WITH WOUND DEHISCENCE AND A HEMATOMA. THE POCKET WAS EVACUATED, AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Wound Dehiscence

  MAUDE report 9673171 ↗
• InjuryAug 26, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED MULTIPLE SHOCKS FOR VENTRICULAR TACHYCARDIA (VT) DETECTION THAT WAS PROBABLY SINUS TACHYCARDIA (ST) IN THE VT ZONE. IT WAS NOTED THAT THE WAVELET WITHHELD UNTIL A PERCENT MATCH CHANGED. 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 8930128 ↗
• InjuryDec 18, 2018Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING THERAPY FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). A REMOTE TRANSMISSION WAS SENT. INFORMATION RECEIVED ON THE REMOTE TRANSMISSION WAS REVIEWED BY QUALIFIED PERSONNEL. IT WAS DETERMINED THAT THE DEVICE HAD MISDETECTED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (AF W/RVR) AS A VENTRICULAR FIBRILLATION (VF) EPISODE, RESULTING IN THE PATIENT RECEIVING AN INAPPROPRIATE THERAPY. FOLLOW UP WAS CONDUCTED WITH THE PATIENTS LISTED CLINIC. THE HEALTHCARE PROFESSIONAL (HCP) WAS ABLE TO VERIFY THAT THE PATIENT HAS NOT BEEN SEEN IN-OFFICE YET AND THEREFORE, NO REPROGRAMMING HAS BEEN COMPLETED AT THIS TIME. 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 8174886 ↗