FDA Device recall Z-1489-2022
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4
- FDA Device
- Class I
- ongoing
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class I recall of Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing there is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1489-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-06-22 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
Product
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
Reason
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Identifiers
| code_info | a. Model Numbers: DVPC3D1: GTIN 00763000178543, Serial Numbers: RSG600007S, RSG600008S, RSG600009S, RSG600010S, RSG…a. Model Numbers: DVPC3D1: GTIN 00763000178543, Serial Numbers: RSG600007S, RSG600008S, RSG600009S, RSG600010S, RSG600011S, RSG600012S, RSG600013S, RSG600014S, RSG600017S, RSG600018S, RSG600020S, RSG600022S, RSG600023S, RSG600024S, RSG600025S, RSG600026S, RSG600027S, RSG600028S, RSG600029S, RSG600030S, RSG600031S, RSG600033S, RSG600036S, RSG600039S, RSG600040S, RSG600041S, RSG600042S, RSG600043S, RSG600045S, RSG600047S, RSG600049S, RSG600050S, RSG600052S, RSG600053S, RSG600054S, RSG600056S, RSG600057S, RSG600058S, RSG600059S, RSG600060S, RSG600063S, RSG600065S, RSG600066S, RSG600068S, RSG600070S, RSG600072S, RSG600073S, RSG600074S, RSG600075S, RSG600079S, RSG600084S, RSG600087S, RSG600088S, RSG600089S, RSG600098S, RSG600101S, RSG600103S, RSG600105S, RSG600305S, RSG600306S, RSG600310S, RSG600311S, RSG600313S, RSG600314S, RSG600315S, RSG600316S, RSG600317S, RSG600319S, RSG600320S, RSG600322S, RSG600324S, RSG600325S, RSG600327S, RSG600330S, RSG600332S, RSG600333S, RSG600334S, RSG60033 |
|---|
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-1489-2022%22
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