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Boston Scientific Corporation recalls AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105
Recalled December 25, 2019 · FDA recall Z-0717-2020 · Boston Scientific
Hazard
Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual. · FDA Class II
Units
169 units ((OUS: 44 US: 125)
Sold at
Worldwide distribution - US Nationwide distribution and country of Canada.
Description
Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
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.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →