FDA Device recall Z-1728-2023
ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4
- 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 DF4, Model Number DDPC3D4 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-1728-2023 |
| 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 DF4, Model Number DDPC3D4; 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 00763000178437, Lot Serial Numbers: RSQ600736S, RSQ600745S, RSQ600905S, RSQ600975S, RSQ601406S, RSQ600113S, RSQ60…GTIN 00763000178437, Lot Serial Numbers: RSQ600736S, RSQ600745S, RSQ600905S, RSQ600975S, RSQ601406S, RSQ600113S, RSQ600114S, RSQ600115S, RSQ600255S, RSQ600256S, RSQ600257S, RSQ600258S, RSQ600261S, RSQ600740S, RSQ601122S, RSQ601137S, RSQ601177S, RSQ601178S, RSQ601179S, RSQ601181S, RSQ601227S, RSQ601228S, RSQ601229S, RSQ601375S, RSQ601377S, RSQ600055S, RSQ600163S, RSQ600164S, RSQ600936S, RSQ601151S, RSQ600049S, RSQ600051S, RSQ600713S, RSQ600991S, RSQ601411S, RSQ601416S, RSQ600218S, RSQ600237S, RSQ600679S, RSQ600712S, RSQ600723S, RSQ600772S, RSQ600074S, RSQ600090S, RSQ600012S, RSQ600053S, RSQ600811S, RSQ600843S, RSQ600912S, RSQ600913S, RSQ600195S, RSQ600894S, RSQ600981S, RSQ600748S, RSQ601201S, RSQ601378S, RSQ601479S, RSQ601490S, RSQ600782S, RSQ600665S, RSQ600091S, RSQ600105S, RSQ600106S, RSQ600130S, RSQ600174S, RSQ600183S, RSQ600185S, RSQ600216S, RSQ600767S, RSQ600788S, RSQ600799S, RSQ601445S, RSQ601447S, RSQ601448S, RSQ601451S, RSQ601452S, RSQ600704S, RSQ600743S, RSQ600773S, RSQ600808S |
|---|
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-1728-2023%22
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