FDA Device recall Z-1788-2023
CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ 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-1788-2023 |
| 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
CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; 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 00763000178253, Lot Serial Numbers: RTS600109S, RTS600115S, RTS600751S, RTS600754S, RTS600962S, RTS600827S, RTS60…GTIN 00763000178253, Lot Serial Numbers: RTS600109S, RTS600115S, RTS600751S, RTS600754S, RTS600962S, RTS600827S, RTS600976S, RTS600761S, RTS600116S, RTS600128S, RTS600174S, RTS600280S, RTS600285S, RTS600674S, RTS600094S, RTS600271S, RTS600277S, RTS600961S, RTS600987S, RTS601452S, RTS600164S, RTS600168S, RTS600203S, RTS600209S, RTS600222S, RTS600375S, RTS600636S, RTS600652S, RTS600734S, RTS600800S, RTS600876S, RTS600127S, RTS600189S, RTS600170S, RTS600171S, RTS600251S, RTS600459S, RTS600460S, RTS600464S, RTS600537S, RTS600608S, RTS600792S, RTS601104S, RTS601108S, RTS600087S, RTS600091S, RTS601032S, RTS600079S, RTS600080S, RTS600081S, RTS600083S, RTS600119S, RTS600161S, RTS600255S, RTS600258S, RTS600261S, RTS600316S, RTS600322S, RTS600418S, RTS600812S, RTS601439S, RTS601440S, RTS601454S, RTS600198S, RTS600744S, RTS600831S, RTS600843S, RTS600963S, RTS600984S, RTS600989S, RTS601015S, RTS601016S, RTS601434S, RTS601436S, RTS602647S, RTS600836S, RTS600092S, RTS600135S, RTS600136S, RTS600137S |
|---|
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-1788-2023%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.