FDA Device recall Z-1268-2022
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4
- FDA Device
- Class II
- ongoing
- Published 2022-06-22
On 2022-06-22 the FDA classified a Class II recall of Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1268-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-12 |
| Published | 2022-06-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1
Reason
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Identifiers
| code_info | a) Crome VR: DVPC3D1, DVPC3D4; Model DVPC3D1: GTIN 00763000178536, Serial Numbers: RSG600215S, RSG600212S, RSG60019…a) Crome VR: DVPC3D1, DVPC3D4; Model DVPC3D1: GTIN 00763000178536, Serial Numbers: RSG600215S, RSG600212S, RSG600196S, RSG600280S, RSG600223S, RSG600208S, RSG600106S, RSG600094S, RSG600125S, RSG600193S, RSG600006S, RSG600123S, RSG600016S, RSG600136S, RSG600249S, RSG600113S, RSG600395S, RSG600173S, RSG600118S, RSG600116S, RSG600112S, RSG600130S, RSG600111S, RSG600191S, RSG600205S, RSG600143S, RSG600175S, RSG600209S, RSG600272S, RSG600167S, RSG600187S, RSG600077S, RSG600162S, RSG600253S, RSG600245S, RSG600131S, RSG600145S, RSG600237S, RSG600107S, RSG600220S, RSG600037S, RSG600119S, RSG600144S, RSG600231S, RSG600163S, RSG600185S, RSG600210S, RSG600148S, RSG600171S, RSG600157S, RSG600172S, RSG600137S, RSG600201S, RSG600190S, RSG600114S, RSG600247S, RSG600183S, RSG600278S, RSG600243S, RSG600246S, RSG600166S, RSG600152S, RSG600228S, RSG600204S, RSG600242S, RSG600126S, RSG600141S, RSG600138S, RSG600174S, RSG600122S, RSG600200S, RSG600225S, RSG600232S, RSG600140S, RSG600233S, RSG600086S, R |
|---|
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-1268-2022%22
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