Visia AF MRI™ S VR SureScan™ DVFC3D1 (UDI 00643169717206)Recalls & reported problems

Medtronic, Inc. · ICD-VR DVFC3D1 VISIA MRI S US DF1 · Class 3 · Implant

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

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169717206), received between Jun 5, 2017 and Mar 29, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Sensing Problem” (1 report).

2 FDA recall records 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Feb 3, 2021Class IOpen, Classified
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
Z-1305-2021 · Root cause: Device Design · Recall details · FDA record ↗
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

Device problems

Device Sensing Problem1
Mechanical Problem1
Premature Discharge of Battery1

Patient problems

Dyspnea1
No Clinical Signs, Symptoms or Conditions1
No Known Impact Or Consequence To Patient1
Ventricular Tachycardia1

Recent adverse event reports

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

InjuryMar 29, 2024Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. 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 19008299 ↗
InjuryJun 18, 2019Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH AND VENTRICULAR TACHYCARDIA (VT). THE PATIENT HAD TO BE EXTERNALLY CARDIOVERTED. IT WAS ALSO NOTED THAT THE DEVICE WAVELET DISCRIMINATOR WAS DELAYING DETECTION OF VT/VENTRICULAR FIBRILLATION (VF) FOR WHAT APPEARED TO BE TRUE VT EPISODES. THE DEVICE WAS ALSO CATEGORIZING ATRIAL FIBRILLATION (AF) EPISODES AS AF WHEN THEY WERE NOT TRUE AF EPISODES. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Dyspnea; Ventricular Tachycardia
MAUDE report 8708349 ↗
MalfunctionJun 5, 2017Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT AT THE TIME OF THE IMPLANT PROCEDURE THE SET SCREW COULD NOT BE TIGHTENED. A DIFFERENT DEVICE WAS IMPLANTED AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6610646 ↗

Device details

UDI-DI	`00643169717206`
Brand	Visia AF MRI™ S VR SureScan™
Model	DVFC3D1
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

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EMBLEM™ S-ICD A209
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EMBLEM™ S-ICD 3501
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Cobalt™ XT DR MRI SureScan™ DDPA2D4
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ENDOTAK RELIANCE® G 0185
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VIGILANT™ EL ICD DR D233
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9 deaths1,563 reports
Evera MRI™ XT DR SureScan® DDMB1D4
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1 recall35 deaths1,426 reports
Durata™ 7122
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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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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