FDA Device recall Z-1806-2023
ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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 resynch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1806-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-10 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
Reason
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.
Identifiers
| code_info | GTIN 00643169717992, Lot Serial Numbers: PLX607314S, PLX608121S, PLX612778S, PLX613087S, PLX604547S, PLX610926S, PLX60…GTIN 00643169717992, Lot Serial Numbers: PLX607314S, PLX608121S, PLX612778S, PLX613087S, PLX604547S, PLX610926S, PLX606361S, PLX608125S, PLX610724S, PLX610983S, PLX609285S, PLX608127S, PLX608938S, PLX610866S, PLX612123S, PLX608086S, PLX608118S, PLX609410S, PLX610864S, PLX610961S, PLX610967S, PLX611934S, PLX611951S, PLX614024S, PLX614073S, PLX608054S, PLX605322S, PLX614114S, PLX607228S, PLX607330S, PLX607943S, PLX613085S, PLX609803S, PLX607928S, PLX605323S, PLX607310S, PLX607333S, PLX606750S, PLX608915S, PLX608983S, PLX609494S, PLX610736S, PLX610740S, PLX610953S, PLX610949S, PLX612097S, PLX608914S, PLX607332S, PLX607785S, PLX607788S, PLX609693S, PLX609858S, PLX608510S, PLX607200S, PLX610731S, PLX606698S, PLX607506S, PLX610276S, PLX606134S, PLX605235S, PLX606368S, PLX612749S, PLX607386S, PLX606748S, PLX610920S, PLX614233S, PLX607508S, PLX612649S, PLX612650S, PLX608980S, PLX609862S, PLX604556S, PLX610980S, PLX607566S, PLX608469S, PLX610900S, PLX606141S, PLX608096S, PLX608113S, PLX609491S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1806-2023%22
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