Evera MRI™ XT VR SureScan® DVMB1D4 (UDI 00643169720558)Recalls & reported problems

Medtronic, Inc. · ICD DVMB1D4 EVERA MRI VR XT DF4 US · Class 3 · Implant

All models of Evera MRI XT VR SureScan (2)

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: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169720558), received between Apr 23, 2020 and Apr 1, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

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.

Reports received per month

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

Recalls naming this device

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-1809-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Electrical /Electronic Property Problem1

Patient problems

Bacteremia1
Bacterial Infection1
Endocarditis1
No Patient Involvement1
Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryApr 1, 2026Adverse 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 (MSSA) BACTEREMIA INFECTION. THE PATIENT ALSO EXPERIENCED ENDOCARDITIS. IN ADDITION, LEAD VEGETATION WAS CONFIRMED VIA T RANSESOPHAGEAL ECHOCARDIOGRAM (TEE). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Bacteremia; Bacterial Infection; Endocarditis; Unspecified Infection
MAUDE report 24753512 ↗
MalfunctionApr 23, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED LOW TELEMETRY BATTERY VOLTAGE/GREY BAR BATTERY VOLTAGE INDICATOR. THE DEVICE WAS NOT UTILIZED AND THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9992917 ↗

Device details

UDI-DI	`00643169720558`
Brand	Evera MRI™ XT VR SureScan®
Model	DVMB1D4
Company	Medtronic, Inc.
Product code	NVZ · Pulse generator, permanent, implantable
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	Nov 17, 2025

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 Pulse generator, permanent, implantable devices

Assurity™ PM2240
St. Jude Medical, Inc. · Pulse generator, permanent, implantable
1 recall84 deaths4,076 reports
Fortify Assura™ CD2357-40Q
St. Jude Medical, Inc. · Pulse generator, permanent, implantable
63 deaths3,571 reports
Advisa DR MRI™ SureScan® A2DR01
Medtronic, Inc. · Pulse generator, permanent, implantable
51 deaths2,298 reports
Fortify Assura™ CD1357-40Q
St. Jude Medical, Inc. · Pulse generator, permanent, implantable
35 deaths1,933 reports
Ellipse™ CD2411-36Q
St. Jude Medical, Inc. · Pulse generator, permanent, implantable
42 deaths1,498 reports
Fortify Assura™ CD2357-40C
St. Jude Medical, Inc. · Pulse generator, permanent, implantable
25 deaths1,378 reports
Accent® DR RF
St. Jude Medical, Inc. · Pulse generator, permanent, implantable
73 deaths1,370 reports
Edora 8 DR-T 407145
BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable
10 deaths982 reports

All Pulse generator, permanent, implantable 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.

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