FDA Device recall Z-1785-2023
CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1
- 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 DF1, Model Number DTPC2D1 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-1785-2023 |
| 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 DF1, Model Number DTPC2D1; 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 00763000178307, Lot Serial numbers: RTX600076S, RTX600084S, RTX600139S, RTX600148S, RTX600114S, RTX600308S, RTX60…GTIN 00763000178307, Lot Serial numbers: RTX600076S, RTX600084S, RTX600139S, RTX600148S, RTX600114S, RTX600308S, RTX600386S, RTX600327S, RTX600334S, RTX600372S, RTX600046S, RTX600048S, RTX600066S, RTX600108S, RTX600261S, RTX600345S, RTX600586S, RTX600382S, RTX600388S, RTX600064S, RTX600069S, RTX600096S, RTX600377S, RTX600360S, RTX600581S, RTX600158S, RTX600306S, RTX600713S, RTX600100S, RTX600319S, RTX600594S, RTX600720S, RTX600727S, RTX600045S, RTX600153S, RTX600157S, RTX600326S, RTX600081S, RTX600146S, RTX600055S, RTX600058S, RTX600143S, RTX600314S, RTX600323S, RTX600332S, RTX600344S, RTX600693S, RTX600307S, RTX600310S, RTX600317S, RTX600588S, RTX600705S, RTX600072S, RTX600095S, RTX600147S, RTX600695S, RTX600698S, RTX600309S, RTX600792S, RTX600167S, RTX600807S, RTX600387S, RTX600086S, RTX600322S, RTX600343S, RTX600365S, RTX600091S, RTX600124S, RTX600597S, RTX600688S, RTX600689S, RTX600799S, RTX600800S, RTX600085S, RTX600087S, RTX600312S, RTX600019S, RTX600120S, RTX600137S, RTX600260S |
|---|
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-1785-2023%22
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