FDA Device recall Z-1745-2023
CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1 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-1745-2023 |
| 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
CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; 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 00643169720350, Lot Serial Numbers: BLS604430S, BLS604248S, BLS604229S, BLS604258S, BLS604234S, BLS604223S, BLS60…GTIN 00643169720350, Lot Serial Numbers: BLS604430S, BLS604248S, BLS604229S, BLS604258S, BLS604234S, BLS604223S, BLS604309S, BLS604224S, BLS604227S, BLS604222S, BLS604308S, BLS604256S, BLS604257S, BLS604310S, BLS604313S, BLS604245S, BLS604253S, BLS604252S, BLS604239S, BLS604226S, BLS604371S, BLS604380S, BLS604417S, BLS604419S, BLS604432S, BLS604560S, BLS604562S, BLS604366S, BLS604368S, BLS604375S, BLS604376S, BLS604169S, BLS604170S, BLS604360S, BLS604365S, BLS604369S, BLS604372S, BLS604379S, BLS604525S, BLS604554S, BLS604572S, BLS604363S, BLS604171S, BLS604361S, BLS604377S, BLS604378S, BLS604418S, BLS604428S, BLS604434S, BLS604556S, BLS604561S, BLS604567S, BLS604571S, BLS604563S, BLS604362S, BLS604364S, BLS604370S, BLS604373S, BLS604422S, BLS604523S, BLS604524S, BLS604543S, BLS604548S, BLS604564S, BLS604570S, BLS604279S, BLS604280S, BLS604281S, BLS604316S, BLS604320S, BLS604321S, BLS604322S, BLS604323S, BLS604324S, BLS604326S, BLS604328S, BLS604317S, BLS604318S, BLS604319S, BLS604416S |
|---|
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-1745-2023%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.