FDA Device recall Z-1797-2023
ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1 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-1797-2023 |
| 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 DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; 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 00643169218017, Lot Serial numbers: BWK607537S, BWK607358S, BWK607401S, BWK607460S, BWK607496S, BWK607540S, BWK60…GTIN 00643169218017, Lot Serial numbers: BWK607537S, BWK607358S, BWK607401S, BWK607460S, BWK607496S, BWK607540S, BWK607351S, BWK607371S, BWK607254S, BWK607394S, BWK607446S, BWK607457S, BWK607473S, BWK607498S, BWK607503S, BWK607536S, BWK607381S, BWK607393S, BWK607369S, BWK607474S, BWK607432S, BWK607439S, BWK607523S, BWK607448S, BWK607526S, BWK607383S, BWK607434S, BWK607463S, BWK607360S, BWK607437S, BWK607472S, BWK607451S, BWK607449S, BWK607436S, BWK607527S, BWK607361S, BWK607275S, BWK607326S, BWK607343S, BWK607384S, BWK607391S, BWK607479S, BWK607501S, BWK607507S, BWK607508S, BWK607518S, BWK607520S, BWK607535S, BWK607544S, BWK607327S, BWK607379S, BWK607521S, BWK607382S, BWK607502S, BWK607366S, BWK607386S, BWK607441S, BWK607468S, BWK607497S, BWK607465S, BWK607455S, BWK607470S, BWK607376S, BWK607529S, BWK607456S, BWK607509S, BWK607505S, BWK607378S, BWK607444S, BWK607297S, BWK607348S, BWK607447S, BWK607395S, BWK607464S, BWK607485S, BWK607534S, BWK607442S, BWK607347S, BWK607389S, BWK607400S |
|---|
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-1797-2023%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.