FDA Device recall Z-1787-2023
CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1
- 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 DF1, Model Number DTPC2Q1 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-1787-2023 |
| 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 DF1, Model Number DTPC2Q1; 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 00763000178260, Lot Serial Numbers: RTT600077S, RTT600166S, RTT600169S, RTT600064S, RTT600083S, RTT600071S, RTT60…GTIN 00763000178260, Lot Serial Numbers: RTT600077S, RTT600166S, RTT600169S, RTT600064S, RTT600083S, RTT600071S, RTT600042S, RTT600028S, RTT600107S, RTT600034S, RTT600421S, RTT600432S, RTT600434S, RTT600574S, RTT600161S, RTT600054S, RTT600160S, RTT600231S, RTT600431S, RTT600045S, RTT600165S, RTT600022S, RTT600062S, RTT600091S, RTT600195S, RTT600430S, RTT600437S, RTT600438S, RTT600125S, RTT600533S, RTT600427S, RTT600481S, RTT600111S, RTT600128S, RTT600040S, RTT600066S, RTT600046S, RTT600573S, RTT600322S, RTT600076S, RTT600024S, RTT600134S, RTT600150S, RTT600531S, RTT600047S, RTT600086S, RTT600220S, RTT600059S, RTT600063S, RTT600426S, RTT600530S, RTT600075S, RTT600095S, RTT600149S, RTT600537S, RTT600541S, RTT600546S, RTT600549S, RTT600550S, RTT600552S, RTT600716S, RTT600889S, RTT600093S, RTT600057S, RTT600156S, RTT600157S, RTT600037S, RTT600429S, RTT600236S, RTT600422S, RTT600436S, RTT600143S, RTT600507S, RTT600065S, RTT600072S, RTT600435S, RTT600056S, RTT600073S, RTT600098S, RTT600067S |
|---|
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-1787-2023%22
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