Visia AF™ VR DVAB1D1 (UDI 00643169720619)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169720619), received between Jan 8, 2019 and Nov 3, 2025 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (10 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 18, 2026.

Recalls naming this device

1. May 10, 2023Class IOpen, 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-1789-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT POST THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE REPLACEMENT THAT THEY DEVELOPED AN INFECTION AFTER THE PROCEDURE. THE INFECTION WAS TREATED AND THE DEVICE WAS PLACED ON THE RIGHT SIDE. THE PATIENT STATED THAT THEY EXPERIENCED A LUMP BETWEEN THEIR DEVICE AND CHEST. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 23459302 ↗
• InjuryMay 9, 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 POSSIBLE INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE SINGLE CHAMBER DEVICE 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 21994373 ↗
• InjuryNov 12, 2024Pacing 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 DURING SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). 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 20663524 ↗
• InjuryMay 1, 2024Failure to Deliver Shock/Stimulation; Pacing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Pacing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT REPROGRAMMING OCCURRED. THE LEAD REMAINS IN USE.

  Patient problems: Tachycardia

  MAUDE report 19224774 ↗
• InjuryFeb 26, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR SUPRA VENTRICULAR TACH YCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). IT WAS NOTED THAT THE QRS MORPHOLOGY WAS SIMILAR TO INTRINSIC QRS BUT APPEARED TO BE NARROW. 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 18779471 ↗
• InjuryDec 18, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE DISCRIMINATOR FEATURE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD POTENTIALLY INAPPROPRIATELY WITHHELD THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT), DURING THE PATIENT'S VENTRICULAR TACHYCARDIA (VT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 18346039 ↗
• MalfunctionJun 19, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INAPPROPRIATELY CLASSIFYING THE PATIENT'S RHYTHM AS ATRIAL FIBRILLATION (AF). IT WAS NOTED THAT P WAVES WERE CONSISTENT BUT R-R INTERVALS SHOWED A HIGH DEGREE OF VARIABILITY. 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 17153908 ↗
• InjuryApr 27, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SHOCKS FOR DETECTED VENTRICULAR FIBRILLATION (VF) THAT WAS POSSIBLY SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 11732813 ↗
• InjuryAug 7, 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) AND RIGHT VENTRICULAR (RV) LEAD WERE EXTRACTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10378637 ↗
• MalfunctionAug 3, 2020Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT VENTRICULAR TACHYCARDIA (VT) MONITORED EPISODES MAY BE SVT (SUPRA VENTRICULAR TACHYCARDIA), BUT WAVELET DID NOT MATCH. IT IS POSSIBLE MISCLASSIFIED EPISODE IS SUSPECTED OF THE DEVICE. 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 10355691 ↗
• MalfunctionJul 20, 2020Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEVERAL VENTRICULAR TACHYCARDIA (VT) EVENT THAT HAD RATES JUST BELOW THE DETECTION LIMIT AND WAS NOT TREATED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN FELT THAT THE DEVICE SHOULD HAVE DETECTED AND TREATED THE ARRHYTHMIA. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Tachycardia

  MAUDE report 10300021 ↗
• InjuryJun 29, 2020High impedance; Mechanical Problem; Misconnection; Over-Sensing; High Capture Threshold; High impedance; Mechanical Problem; Misconnection; Over-Sensing; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THERE WAS A SETSCREW ISSUE WITH THE DEVICE AND THE LEAD WAS NOT FULLY DEPLOYED. A REVISION PROCEDURE TOOK PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10209548 ↗
• InjuryFeb 11, 2020Electrical /Electronic Property Problem; Pacing Problem; Electrical /Electronic Property Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT FELT DYSPNEA WHEN BENDING OVER AS WELL AS LATERAL STIMULATION. IT WAS DETERMINED THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD INCREASED VENTRICULAR PACING. THE ICD WAS REPROGRAMMED AND 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: Dyspnea; Muscle Stimulation

  MAUDE report 9693833 ↗
• MalfunctionFeb 9, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT¿S HEART RATE WAS VERY LOW AND THE REGISTERED NURSE (RN) SUSPECTS THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY NOT BE FUNCTIONING CORRECTLY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 9685147 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION OCCURRED APPROXIMATELY TWO MONTHS POST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGEOUT PROCEDURE AFTER HEMATOMA. THE ICD SYSTEM WAS EXPLANTED AND ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 9545126 ↗
• MalfunctionDec 30, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN COULD NOT GET THE WRENCH IN THE RV (RIGHT VENTRICULAR) COIL HOLE OF THE DEVICE HEADER TO TIGHTEN THE SETSCREW. IT WAS NOTED THAT ANOTHER WRENCH WAS TRIED BUT WAS NOT SUCCESSFUL. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9530375 ↗
• InjuryDec 17, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO POSSIBLE ATRIAL FIBRILLATION (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 9481010 ↗
• InjurySep 20, 2019Adverse 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9099892 ↗
• MalfunctionJan 11, 2019Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUBJECT TO AN OFF-LABEL MAGNETIC RESONANCE IMAGING (MRI) SCAN AS THE ICD IS NOT A MRI CONDITIONAL SYSTEM. IT WAS NOTED THAT THE DEVICE DETECTIONS WERE PROGRAMMED OFF AND PACING PROGRAMMED ASYNCHRONOUS DURING THE MRI SCAN. FOLLOWING THE MRI, THE PHYSICIAN ASSISTANT ATTEMPTED TO RE-INTERROGATE THE ICD BUT WAS UNABLE. A DIFFERENT PROGRAMMER WAS TRIED BUT THAT DID NOT WORK EITHER. THE ABOUT FIFTEEN MINUTES LATER THE PHYSICIAN ASSISTANT ATTEMPTED TO INTERROGATE THE ICD AGAIN AND WAS ABLE TO REGAIN TELEMETRY. PER THE PHYSICIAN ASSISTANT THE ICD WAS THEN FUNCTIONING WITH NO KNOWN ISSUES. THE 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 8240816 ↗
• MalfunctionJan 8, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ATTEMPTED TO BE IMPLANTED BUT NOT USED. UPON INSERTING AND REMOVING THE RIGHT VENTRICULAR (RV) LEAD, THE SET SCREW CAME OUT OF THE DEVICE HEADER GROMMET DF-1 PORT. THE DEVICE WAS REMOVED FROM IMPLANT AND THE OLD DEVICE WAS RE-CONNECTED TO THE RV LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8229800 ↗