FDA Device recall Z-0717-2020
AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650…
- FDA Device
- Class II
- terminated
- Published 2019-12-25
On 2019-12-25 the FDA classified a Class II recall of AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650… by Boston Scientific, citing missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0717-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-08 |
| Published | 2019-12-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet allows for percutaneous removal of thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline jets contained in the catheter shaft. The saline jets create a low-pressure effect to draw thrombus into the catheter, fragment the thrombus, and remove the thrombus from the treatment site. The system consists of a single use Thrombectomy Set (several models available) and a free standing mobile Console.
Reason
Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
Identifiers
| code_info | UPN GTN SERIAL NUMBER 105650-001D 08714729892182¿ U2541 105650-001D 08714729892…UPN GTN SERIAL NUMBER 105650-001D 08714729892182¿ U2541 105650-001D 08714729892182¿ U2893 105650-001D 08714729892182¿ U3139 105650-001D 08714729892182¿ U4146 105650-001D 08714729892182¿ U5058 105650-001D 08714729892182¿ U5136 105650-001H 08714729890591¿ U2259 105650-001H 08714729890591¿ U2262 105650-001H 08714729890591¿ U2379 105650-001H 08714729890591¿ U2552 105650-001H 08714729890591¿ U2613 105650-001H 08714729890591¿ U2851 105650-001H 08714729890591¿ U2976 105650-001H 08714729890591¿ U3460 105650-001H 08714729890591¿ U3535 105650-001H 08714729890591¿ U3611 105650-001H 08714729890591¿ U3731 105650-001H 08714729890591¿ U3819 105650-001H 08714729890591¿ U3939 105650-001H 08714729890591¿ U6400 105650-001R 08714729890607¿ U2003 105650-001R 08714729890607¿ U2004 105650-001R 08714729890607¿ U2007 105650-001R 08714729890607¿ U2021 105650-001R 08714729890607¿ U2023 105650-001R 08714729890607¿ U2025 105650-001R 08714729890607¿ U |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0717-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.