FDA Device recall Z-1792-2023
ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4 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-1792-2023 |
| 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 AF XT OUS DF4, Model Number DDVAB2D4; 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 00643169720763, Lot Serial Numbers: BWT600023S, BWT600013S, BWT600014S, BWT600025S, BWT600029S, BWT600030S, BWT60…GTIN 00643169720763, Lot Serial Numbers: BWT600023S, BWT600013S, BWT600014S, BWT600025S, BWT600029S, BWT600030S, BWT600032S, BWT600033S, BWT600034S, BWT600024S,; GTIN 00763000052706, Lot Serial Numbers: BWT600040S, BWT600038S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Medtronic Cardiac Rhythm And Heart Failure Crhf
- CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf
All Medtronic Cardiac Rhythm And Heart Failure Crhf recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1792-2023%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.