Visia AF MRI™ VR SureScan™ DVFB1D4 (UDI 00643169929913)Recalls & reported problems

Summary

The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 00643169929913), received between Oct 6, 2017 and Sep 17, 2026 — classified as 2 deaths, 138 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (59 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 18, 2026.

Recalls naming this device

1. Dec 19, 2017Class ITerminated

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

   Z-0588-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 173 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced an unspecified infection with discomfort, fever, and pain. The patient was hospitalized and the device system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Fever; Pain; Unspecified Infection

  MAUDE report 50805302 ↗
• InjuryAug 6, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received possibly inappropriate high-voltage therapy for Supra Ventricular Tachycardia (SVT) that the Implantable Cardioverter Defibrillator (ICD) classified as Ventricular Fibrillation (VF). 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 50165477 ↗
• InjuryJul 7, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN PACING IMPEDANCE, A DECREASE IN IMPEDANCE ON BOTH DEFI BRILLATION COILS, AND HIGH CAPTURE THRESHOLDS. THE LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF), WITH THE FIRST SHOCK INDUCING A TRUE VENTRICULAR ARRHYTHMIA. 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); Ventricular Fibrillation

  MAUDE report 25736745 ↗
• MalfunctionJun 29, 2026Over-Sensing; Device-Device Incompatibility

  IT WAS REPORTED THAT OVERSENSING OCCURRED. IT WAS NOTED THAT THE OVERSENSING MAY BE FROM THE PATIENT'S CARDIAC CONTRACTILITY MODULATION (CCM) DEVICE. THE CCM AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE 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 25653897 ↗
• MalfunctionJun 16, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A VENTRICULAR TACHYCARDIA (VT) EPISODE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). IN ADDITION, 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 25520543 ↗
• InjuryJun 1, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). 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 25350500 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacteremia

  MAUDE report 25169183 ↗
• InjuryMar 23, 2026Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE DEVICE POSSIBLY INAPPROPRIATE WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT) THAT WAS DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT) DUE TO WAVELET MATCH SCORES.  THE PATIENT WAS SUBSEQUENTLY APPROPRIATELY TREATED WITH ANTI-TACHYCARDIA PACING THAT BROKE THE RHYTHM.  THE ICD REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663432 ↗
• InjuryFeb 12, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS CONFIRMED TO BE FRACTURED VIA NOISE; HOWEVER, NO PHYSICAL FRACTURE WAS NOTICED ON THE LEAD. DURING THE EXPLANT PROCEDURE, THE LEAD COULD NOT BE EXTRACTED SO IT WAS CAPPED. IT WAS ALSO NOTED THAT THE PATIENT WAS IN NORMAL SINUS RHYTHM, SO THE PHYSICIAN DECIDED TO UPGRADE THE DEVICE AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324542 ↗
• InjuryFeb 5, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THE RV LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR FIBRILLATION (VF). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. FOLLOW UP WITH THE CLINIC LATER REVEALED THAT THE PATIENT PRESENTED WITH CHEST PAIN AND PALPITATIONS. INITIAL PHYSICAL EXAMINATIONS SHOWED THAT THE PATIENT HAD AN IRREGULAR RHYTHM WITH TACHYCARDIA AND ELECTROLYTE ABNORMALITY. A COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) WITH CONTRAST EXAM WAS DONE AND PULMONARY EMBOLISM WAS SUSPECTED WITH HIGH PROBABILITY. THE PATIENT WAS HOSPITALIZED AND MEDICATIONS WERE ADMINISTERED AND ADJUSTED. IT WAS ALSO NOTED THAT PRIOR TO THE EVENT THE PATIENT HAD NOT BEEN TAKING THEIR MEDICATIONS AS PRESCRIBED.

  Patient problems: Chest Pain; Palpitations; Pulmonary Embolism; Shock from Patient Lead(s)

  MAUDE report 24274445 ↗
• MalfunctionJan 6, 2026Battery Problem

  THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973657 ↗
• InjuryDec 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23860767 ↗
• MalfunctionOct 29, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). 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 23416717 ↗
• InjuryOct 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED AND REPLACED DUE TO PHYSICIAN'S MEDICAL JUDGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379139 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED FOR UNKNOWN REASON.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED AN ONGOING TEMPERATURE, SWELLING, AND PAIN AT THE ICD IMPLANT SITE. A CHRONIC POCKET INFECTION WAS CONFIRMED AS EVIDENCED BY A LARGE VOLUME OF FRANK PURULENCE. THE ICD SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions; Pain; Purulent Discharge; Swelling/ Edema

  MAUDE report 22653723 ↗
• InjuryJul 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 ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR POSSIBLE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). 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 22556594 ↗
• InjuryJul 14, 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 RAPID VENTRICULAR RESPONSE (RVR) THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF). SUPRA VENTRICULAR TACHYCARDIA (SVT) WAS IN PROGRESS AT THE TIME OF THERAPY. IN ADDITION, THERE WAS AN ALERT DUE TO SHORT V-V INTERVALS ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RVLEAD 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 22498287 ↗
• InjuryJun 26, 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 ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO HAVE EXHIBITED T-WAVE OVERSENSING (TWOS) IN THE PAST. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RV 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 22337616 ↗
• InjuryJun 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A STAPH A INFECTION AND WAS FOUND TO BE SEPTIC. THE ENTIRE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 22303635 ↗
• InjuryJun 10, 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 ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR AN EPISODE DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT) OR THE EPISODE PRIOR THAT WAS DETECTED IN THE SUPRA VENTRICULAR TACHYCARDIA (SVT) ZONE WAS TRUE VENTRICULAR TACHYCARDIA (VT) AND DETECTION WAS DELAYED DUE TO MISCLASSIFICATION. 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); Tachycardia

  MAUDE report 22176645 ↗
• InjuryMay 27, 2025Adverse 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 A METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS INFECTION. FIVE DAYS LATER, A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 22089636 ↗
• InjuryMay 14, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR FIBRILLATION (VF). THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22020405 ↗
• MalfunctionMar 7, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED DATA RECORDING PROBLEM AS THERE WAS EPISODE DATA DISCREPANCY, WHERE THERE WERE TWO EPISODES OF HIGH-RATE NON-SUSTAINED EPISODES THAT DID NOT APPEAR IN THE EPISODE LIST. THERE WAS ALSO FOUR EPISODES OF VENTRICULAR TACHYCARDIA (VT) BUT THERE WERE ONLY TWO IN EPISODE LIST. IT WAS ALSO REPORTED THAT THE THERE WAS AN EPISODE DATA DISCREPANCY ON REMOTE MONITORING NETWORK. IT WAS NOTED THAT THERE WERE TWO HIGH-RATE NON-SUSTAINED EPISODES THAT DID NOT APPEAR IN THE EPISODE LIST. THE DEVICE 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 21547268 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED DIZZINESS AND FAINTING SPELLS. IT WAS NOTED THAT ONCE THE HEALTHCARE PROVIDER CHANGED THE PATIENT¿S BLOOD PRESSURE MEDICATION, THE FAINTING SPELLS NO LONGER OCCURRED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 21445981 ↗
• InjuryFeb 13, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCK FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 21375205 ↗