FDA Device recall Z-1790-2023
ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4 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-1790-2023 |
| 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 DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; 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 00643169720626, Lot Serial Numbers: BWP202537H, BWP202379H, BWP202439H, BWP202454H, BWP202474H, BWP202510H, BWP20…GTIN 00643169720626, Lot Serial Numbers: BWP202537H, BWP202379H, BWP202439H, BWP202454H, BWP202474H, BWP202510H, BWP202522H, BWP202523H, BWP202252H, BWP202639H, BWP202514H, BWP202179H, BWP202398H, BWP202399H, BWP202554H, BWP202420H, BWP202447H, BWP202494H, BWP201863H, BWP202260H, BWP202324H, BWP202359H, BWP202432H, BWP202542H, BWP202643H, BWP202292H, BWP202297H, BWP202365H, BWP202366H, BWP202369H, BWP202549H, BWP202578H, BWP202213H, BWP202287H, BWP202471H, BWP202583H, BWP201864H, BWP202626H, BWP202358H, BWP202331H, BWP202306H, BWP202385H, BWP202272H, BWP202404H, BWP202434H, BWP202453H, BWP202553H, BWP202576H, BWP202586H, BWP202588H, BWP202598H, BWP202544H, BWP202159H, BWP202161H, BWP202162H, BWP202163H, BWP202164H, BWP202165H, BWP202561H, BWP202563H, BWP202467H, BWP202194H, BWP202238H, BWP202460H, BWP202497H, BWP202198H, BWP202532H, BWP202566H, BWP202536H, BWP202180H, BWP202402H, BWP202424H, BWP202429H, BWP202183H, BWP202279H, BWP202362H, BWP202363H, BWP202364H, BWP202496H, BWP202291H |
|---|
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-1790-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.