FDA Device recall Z-1746-2023
CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4 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-1746-2023 |
| 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 DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; 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 00643169720299, Lot Serial Numbers; BLR602282S, BLR602271S, BLR602274S, BLR602363S, BLR602366S, BLR602278S, BLR60…GTIN 00643169720299, Lot Serial Numbers; BLR602282S, BLR602271S, BLR602274S, BLR602363S, BLR602366S, BLR602278S, BLR602289S, BLR602365S, BLR602238S, BLR602293S, BLR602325S, BLR602332S, BLR602333S, BLR602334S, BLR602336S, BLR602337S, BLR602340S, BLR602353S, BLR602360S, BLR602361S, BLR602356S, BLR602236S, BLR602237S, BLR602290S, BLR602296S, BLR602306S, BLR602338S, BLR602341S, BLR602358S, BLR602378S, BLR602335S, BLR602339S, BLR602359S, BLR602308S, BLR602328S, BLR602330S, BLR602331S, BLR602352S, BLR602357S, BLR602390S, BLR602269S, BLR602381S, BLR602382S, BLR602383S, BLR602384S, BLR602387S, BLR602398S, BLR602394S, BLR602395S, BLR602385S, BLR602386S, BLR602388S, BLR602397S, BLR602379S, BLR602380S, BLR602389S, BLR602362S, BLR602377S; GTIN 00643169980112, Lot Serial Numbers: BLR602821S, BLR602777S, BLR602490S, BLR602342S, BLR602492S, BLR602425S, BLR602408S, BLR602430S, BLR602515S, BLR602516S, BLR602518S, BLR602520S, BLR602530S, BLR602531S, BLR602534S, BLR602535S, BLR602537S, BLR602540S, BL |
|---|
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-1746-2023%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.