FDA Device recall Z-1789-2023
ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1 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-1789-2023 |
| 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 DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; 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 00643169720619, Lot Serial Numbers: BWN203363H, BWN203588H, BWN203428H, BWN203504H, BWN203530H, BWN203214H, BWN20…GTIN 00643169720619, Lot Serial Numbers: BWN203363H, BWN203588H, BWN203428H, BWN203504H, BWN203530H, BWN203214H, BWN203258H, BWN203259H, BWN203304H, BWN203477H, BWN203665H, BWN203423H, BWN203403H, BWN203327H, BWN203518H, BWN203790H, BWN203174H, BWN203624H, BWN203750H, BWN203763H, BWN203786H, BWN203745H, BWN203526H, BWN203813H, BWN203168H, BWN203236H, BWN203374H, BWN203463H, BWN203640H, BWN203213H, BWN203431H, BWN203492H, BWN203585H, BWN203436H, BWN203524H, BWN203528H, BWN203809H, BWN203432H, BWN203231H, BWN203199H, BWN203163H, BWN203193H, BWN203306H, BWN203310H, BWN203352H, BWN203373H, BWN203433H, BWN203575H, BWN203611H, BWN203616H, BWN203689H, BWN203732H, BWN203739H, BWN203749H, BWN203796H, BWN203799H, BWN203803H, BWN203181H, BWN203642H, BWN203202H, BWN203758H, BWN203671H, BWN203769H, BWN203357H, BWN203248H, BWN203253H, BWN203448H, BWN203664H, BWN203733H, BWN203260H, BWN203347H, BWN203408H, BWN203422H, BWN203535H, BWN203582H, BWN203712H, BWN203770H, BWN203697H, BWN203205H, BWN203410H |
|---|
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-1789-2023%22
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