FDA Device recall Z-1822-2023
ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1 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-1822-2023 |
| 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 VR MRI IS1 DF1, Model Number DVPC3D1; 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 00763000178536, Lot Serial Numbers: RSG600215S, RSG600106S, RSG600196S, RSG600208S, RSG600223S, RSG600280S, RSG60…GTIN 00763000178536, Lot Serial Numbers: RSG600215S, RSG600106S, RSG600196S, RSG600208S, RSG600223S, RSG600280S, RSG600125S, RSG600193S, RSG600006S, RSG600016S, RSG600123S, RSG600136S, RSG600573S, RSG600113S, RSG600249S, RSG600395S, RSG600579S, RSG600173S, RSG600111S, RSG600112S, RSG600116S, RSG600118S, RSG600130S, RSG600143S, RSG600175S, RSG600191S, RSG600205S, RSG600209S, RSG600272S, RSG600564S, RSG600167S, RSG600187S, RSG600077S, RSG600131S, RSG600145S, RSG600162S, RSG600245S, RSG600253S, RSG600512S, RSG600519S, RSG600037S, RSG600536S, RSG600544S, RSG600210S, RSG600643S, RSG600642S, RSG600122S, RSG600138S, RSG600174S, RSG600200S, RSG600225S, RSG600233S, RSG600585S, RSG600134S, RSG600168S, RSG600148S, RSG600132S, RSG600240S, RSG600055S, RSG600121S, RSG600179S, RSG600186S, RSG600158S, RSG600181S, RSG600219S, RSG600108S, RSG600164S, RSG600255S, RSG600511S, RSG600109S, RSG600110S, RSG600115S, RSG600117S, RSG600178S, RSG600250S, RSG600560S, RSG600083S, RSG600581S, RSG600639S, RSG600140S |
|---|
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-1822-2023%22
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