Visia AF MRI™ S VR SureScan™ DVFC3D4 (UDI 00643169988644)Recalls & reported problems

Medtronic, Inc. · ICD DVFC3D4 VISIA AF S VR DF4 MRI US · Class 3 · Implant

All models of Visia AF MRI S VR SureScan (7)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169988644), received between Mar 8, 2019 and May 31, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Sensing Problem” (3 reports).

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.

Most reported problems

Device problems

Device Sensing Problem3
Inappropriate/Inadequate Shock/Stimulation2
Pacing Problem1

Patient problems

Shock from Patient Lead(s)2
Chest Pain1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 31, 2023Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO CHEST PAIN. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INTERROGATED AND SHOWED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) FOR A DEVICE-CLASSIFIED EPISODE IN THE VENTRICULAR FIBRILLATION (VF) ZONE. IT WAS ALSO NOTED THAT A DISCRIMINATOR DETERMINED THE RHYTHM TO ACTUALLY HAVE BEEN SUPRA VENTRICULAR TACHYCARDIA (SVT), HOWEVER THE DISCRIMINATOR WAS PROGRAMMED TO MONITOR ONLY AND THE ATP WAS NOT WITHHELD AS A RESULT. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Chest Pain
MAUDE report 17029959 ↗
InjuryAug 2, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AN ATRIAL ARRHYTHMIA FOLLOWED BY RAPID VENTRICULAR RESPONSE AS FAST VENTRICULAR TACHYCARDIA AND DELIVERED MULTIPLE INAPPROPRIATE THERAPIES. 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 15147827 ↗
InjuryMar 8, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ¿BEEPING¿. IN ADDITION, THE PATIENT REPORTED THEY RECEIVED A SHOCK AND SENT A WIRELESS TRANSMISSION THEIR PHYSICIAN. THE PATIENT REPORTED THE PHYSICIAN STATED THAT THE PATIENT WAS IN ATRIAL FIBRILLATION (AF), AND ¿IT SOMEHOW TRICKED MY DEVICE TO THINK MY HEART RATE WAS GOING VERY FAST.¿ 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 8404049 ↗

Device details

UDI-DI	`00643169988644`
Brand	Visia AF MRI™ S VR SureScan™
Model	DVFC3D4
Company	Medtronic, Inc.
Product code	LWS · Implantable cardioverter defibrillator (non-CRT)
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	Not in Commercial Distribution
Record updated	Feb 5, 2021

Device type (GMDN): Single-chamber implantable defibrillator

An implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected a lead(s) that are positioned inside or on one heart chamber (typically right ventricle) to monitor the ECG and to automatically deliver the electrical impulse. It has internal batteries that provide the energy for the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

Other Implantable cardioverter defibrillator (non-CRT) devices

EMBLEM™ MRI S-ICD A219
Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
2 recalls36 deaths15,404 reports
EMBLEM™ S-ICD A209
Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
1 recall7 deaths6,788 reports
EMBLEM™ S-ICD 3501
Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
7 deaths4,936 reports
Cobalt™ XT DR MRI SureScan™ DDPA2D4
Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
3 recalls30 deaths1,603 reports
ENDOTAK RELIANCE® G 0185
Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
9 deaths1,632 reports
VIGILANT™ EL ICD DR D233
Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)
9 deaths1,563 reports
Evera MRI™ XT DR SureScan® DDMB1D4
Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)
1 recall35 deaths1,426 reports
Durata™ 7122
St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)
27 deaths1,377 reports

All Implantable cardioverter defibrillator (non-CRT) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page