Visa AF MRI™ S VR SureScan™ DVFC3D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00643169837829), received between Oct 12, 2018 and Jul 9, 2026 — classified as 1 death, 15 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (4 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-1807-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED ELECTROMAGNETIC INTERFERENCE RESULTING IN INAPPROPRIATE HIGH VOLTAGE THERAPY BEING DELIVERED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25769442 ↗
• MalfunctionApr 30, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE CONTACTED BY THEIR HEALTH CARE PROFESSIONAL WHO STATED THAT SOMETHING WAS WRONG WITH THEIR HEART DEVICE. NO ADDITIONAL ADDITIONAL DETAILS WERE PROVIDED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 25043619 ↗
• MalfunctionDec 22, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REGISTERING EVENTS THAT DIDN¿T GET PICKED UP AT THE DOCTOR¿S OFFICE SIX MONTHS AGO. 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 23870498 ↗
• 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 ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) DETECTED IN THE FAST VENTRICULAR TACHYCARDIA (FVT) 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 22913837 ↗
• DeathFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY "A FEW DAYS" AFTER A SURGERY OCCURRED. IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS "TURNED ON". ADDITIONAL INFORMATION AND A CAUSE OF DEATH WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 21337670 ↗
• InjuryJun 20, 2024Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT WHILE THE PATIENT WAS HAVING A BREAST REDUCTION SURGERY THE MAGNET PLACED OVER THE IMPLANTABLE CARDIOVERTER DEF IBRILLATOR (ICD) WAS MOVED, AND DURING ELECTROCAUTERY THE PATIENT RECEAVED TWO INAPPROPRIATE SHOCKS. 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 19575718 ↗
• MalfunctionJan 24, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PRESYNCOPE. THERE WAS POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING DURING SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED 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: Dizziness

  MAUDE report 18574474 ↗
• MalfunctionDec 6, 2023Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS FURTHER REPORTED THAT ALL OF THE SENSING ISSUES OCCURRED AT THE TIME OF THE SURGERY, AND WAS ATTRIBUTED TO CAUTERY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273779 ↗
• InjurySep 18, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE INITIAL LEAD REVISION WAS DUE TO RIGHT VENTRICULAR (RV) LEAD NOISE. THE LEAD WAS CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765567 ↗
• InjurySep 16, 2022Adverse 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 OF UNKNOWN ORIGIN. THE PATIENT WAS TREATED AND THEN REIMPLANTED WITH A NEW ICD SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15439253 ↗
• MalfunctionAug 4, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT SHORT CIRCUIT PROTECTION WAS TRIGGERED DURING HIGH VOLTAGE THERAPY AND LESS-THAN-PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED. IT WAS ADDITIONALLY NOTED THAT POCKET MANIPULATION/ISOMETRICS WERE PERFORMED AND NO NOISE WAS ABLE TO BE PRODUCED. BOTH THE LEAD AND THE ICD 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 15164634 ↗
• InjuryMay 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A POTENTIAL PERFORMANCE ISSUE. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14495567 ↗
• InjuryJun 1, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT REPROGRAMMING WAS DONE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 11913149 ↗
• MalfunctionMay 4, 2021Signal Artifact/Noise; Electromagnetic Interference; Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED A RIGHT VENTRICULAR LEAD INTEGRITY ALERT (LIA) DUE TO NOISE THAT OCCURRED DURING A SURGICAL 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 11772738 ↗
• InjuryAug 14, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO INFECTION AT THE BOTTOM OF THEIR LEFT BREAST. IT WAS NOTED THAT THE DEVICE HAD MIGRATED FROM THE SUB-PECTORAL TO THE BOTTOM OF LEFT BREAST. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10408433 ↗
• InjuryMay 20, 2020Signal Artifact/Noise; Failure to Capture; Pacing Problem; Under-Sensing; Low impedance; Capturing Problem; Device Sensing Problem; Impedance Problem; Signal Artifact/Noise; Failure to Capture; Pacing Problem; Under-Sensing; Low impedance; Capturing Problem; Device Sensing Problem; Impedance Problem

  IT WAS FURTHER REPORTED THAT THERE HAD BEEN A SPIKE TO HIGH RV PACING IMPEDANCE NOTED, AND REPROGRAMMING WAS PERFORMED TO CHANGE THE PACING AND SENSING VECTORS. THERE WERE MULTIPLE RV LEAD ALERTS NOTED DUE TO A DROP TO ZERO IMPEDANCE IN BIPOLAR CONFIGURATION. THE PATIENT WAS RECENTLY BROUGHT TO THE EMERGENCY ROOM AND HAD EXPERIENCED CARDIAC ARREST AND UNSTABLE VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION (VT/VF). THE PATIENT RECEIVED SHOCK THERAPIES FROM THEIR DEVICE, HOWEVER THERE WERE PERIODS OF VENTRICULAR UNDERSENSING OBSERVED. THE PATIENT REQUIRED EXTERNAL DEFIBRILLATION. AN X-RAY REVEALED THAT THE PATIENT APPEARED TO HAVE TWIDDLER'S SYNDROME. A REVIEW OF DEVICE DATA BY QUALIFIED PERSONNEL NOTED A FLAT AND NOISY LINE ON THE RV CHANNEL. THE RV LEAD WAS INACTIVATED AND REPLACED. THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; Tachycardia; Twiddlers Syndrome; Ventricular Fibrillation

  MAUDE report 10076596 ↗
• InjuryDec 16, 2019Signal Artifact/Noise; Mechanical Problem; Over-Sensing; Signal Artifact/Noise; Mechanical Problem; Over-Sensing

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGEOUT THE RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) WITH NOISE THAT WAS ABLE TO BE REPRODUCED WITH ISOMETRICS AND BY 'TAPPING THE CAN'. IT WAS NOTED THAT PRIOR TO THE ICD CHANGEOUT THERE HAD NOT BEEN ANY NOISE SEEN ON THE DEVICE OR LEAD AND IT WAS ASSUMED THAT THERE WAS A LOOSE SET SCREW. A REVISION PROCEDURE WAS CONDUCTED, AND THE POCKET WAS OPENED. THE CATHODE WAS COMPLETELY THRU THE HEADER, AND A TUG TEST SHOWED NO ISSUE. CABLES WERE CONNECTED AND THE LEAD WAS MANIPULATED WITH NOISE BEING PRESENT, SO THE PHYSICIAN DECIDED TO IMPLANT A NEW RV LEAD AND DF4 CONNECTOR ICD ON THE OFF CHANCE THAT IT WAS A HEADER ISSUE. THE DEVICE WAS EXTRACTED AND REPLACED AND THE LEAD WAS PARTIALLY REMOVED, CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9477322 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED DUE TO INFECTION APPROXIMATELY ONE MONTH FOLLOWING A ROUTINE GENERATOR CHANGE. THE SYSTEM IS SCHEDULED TO BE REPLACED IN THE FUTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9368605 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WITHIN TWO MONTHS AFTER A DEVICE REPLACEMENT PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE REMOVED DUE TO INFECTION/EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 9282189 ↗
• InjuryOct 14, 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 AND REPLACED DUE TO POCKET EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 9188513 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXTRACTED DUE TO A POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8623594 ↗
• InjuryOct 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED DEVELOPING A STAPHYLOCOCCUS INFECTION THAT WENT "BLOOD BORNE". THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WAS REMOVED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7961056 ↗