AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D… — Class II medical device recall Z-0717-2020
Terminated recall by Boston Scientific Corporation, reported 2019-12-25, distributed nationwide. Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
| Recall number | Z-0717-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2019-11-08 |
| Classified | 2019-12-19 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2021-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| UPC / GTIN / UDI-DI | 08714729890591, 08714729890607, 08714729890638, 08714729890683, 08714729890690, 08714729890782, 08714729890843, 08714729891284, 08714729891307, 08714729891314, 08714729891321, 08714729891352, 08714729892182, 08714729892199, 08714729892656 |
| Serial numbers | 08714729890638, 08714729890690, 08714729890782, 08714729890843, 08714729891284, 08714729891314, 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, U2003, U2004, U2007, U2021 and 280 more |
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 for recall
Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0717-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.