FDA Device recall Z-1786-2023
CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4 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-1786-2023 |
| 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 MRI IS1 DF4, Model Number DTPC2D4; 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 00763000178291, Lot Serial numbers: RTW600585S, RTW600307S, RTW600091S, RTW600313S, RTW600121S, RTW600342S, RTW60…GTIN 00763000178291, Lot Serial numbers: RTW600585S, RTW600307S, RTW600091S, RTW600313S, RTW600121S, RTW600342S, RTW600596S, RTW600074S, RTW600144S, RTW600102S, RTW600319S, RTW600578S, RTW600346S, RTW600277S, RTW600309S, RTW600581S, RTW600098S, RTW600118S, RTW600119S, RTW600123S, RTW600133S, RTW600138S, RTW600159S, RTW600168S, RTW600205S, RTW600052S, RTW600067S, RTW600217S, RTW600333S, RTW600592S, RTW600059S, RTW600151S, RTW600169S, RTW600196S, RTW600229S, RTW600304S, RTW600306S, RTW600223S, RTW600062S, RTW600171S, RTW600049S, RTW600057S, RTW600126S, RTW600130S, RTW600153S, RTW600158S, RTW600163S, RTW600181S, RTW600182S, RTW600188S, RTW600204S, RTW600211S, RTW600230S, RTW600240S, RTW600245S, RTW600247S, RTW600249S, RTW600250S, RTW600317S, RTW600323S, RTW600338S, RTW600588S, RTW600589S, RTW600593S, RTW600339S, RTW600819S, RTW600113S, RTW600594S, RTW600120S, RTW600244S, RTW600008S, RTW600056S, RTW600089S, RTW600183S, RTW600239S, RTW600292S, RTW600297S, RTW600069S, RTW600148S, RTW600080S |
|---|
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-1786-2023%22
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