FDA Device recall Z-1727-2023
ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1 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-1727-2023 |
| 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
ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; 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 00763000178413, Lot Serial Numbers: RSP600249S, RSP600057S, RSP600253S, RSP600085S, RSP600014S, RSP600150S, RSP60…GTIN 00763000178413, Lot Serial Numbers: RSP600249S, RSP600057S, RSP600253S, RSP600085S, RSP600014S, RSP600150S, RSP600148S, RSP600089S, RSP600091S, RSP600114S, RSP600189S, RSP600210S, RSP600394S, RSP600130S, RSP600216S, RSP600256S, RSP600386S, RSP600149S, RSP600245S, RSP600066S, RSP600068S, RSP600069S, RSP600083S, RSP600112S, RSP600132S, RSP600136S, RSP600404S, RSP600076S, RSP600731S, RSP600954S, RSP600955S, RSP600953S, RSP600070S, RSP600145S, RSP600157S, RSP600200S, RSP600226S, RSP600082S, RSP600139S, RSP600141S, RSP600152S, RSP600163S, RSP600074S, RSP600732S, RSP600204S, RSP600369S, RSP600726S, RSP600748S, RSP600048S, RSP600080S, RSP600363S, RSP600396S, RSP600397S, RSP600408S, RSP600444S, RSP600544S, RSP600335S, RSP600383S, RSP600400S, RSP600808S, RSP600862S, RSP600939S, RSP600949S, RSP600950S, RSP600218S, RSP600288S, RSP600246S, RSP600193S, RSP600395S, RSP600725S, RSP600360S, RSP600413S, RSP600202S, RSP600736S, RSP600138S, RSP600049S, RSP600065S, RSP600095S, RSP600346S, RSP600372S |
|---|
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-1727-2023%22
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