Recall Z-0717-2020— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2019-11-08, terminated 2021-03-24. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-08
- Terminated
- 2021-03-24
- Firm location
- Marlborough, MA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.