Recall Z-0717-2020 ยท MCX Catheter, Coronary, Atherectomy
Boston Scientific Corporation
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,
| Date | Dec 19, 2019 (initiated Nov 8, 2019) |
| Status | Terminated |
| Reason | Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual. |
| Root cause | Reprocessing Controls |
| Action | Boston Scientific Customer issued notification letters dated 11/08/19 via overnight mail delivery. Letter states reason for recall, health risk and action to take: AngioJet Repaired Consoles located at affected accounts will remain in the field. An AngioJet DFU will be provided to accounts to correct the previous DFU omission with the distribution of the Repaired Console. Your local Sales Representative can answer any questions that you may have regarding this correction. Please pass this notice to any healthcare professional from your organization who needs to be aware and to any organization |
| Quantity | 169 units ((OUS: 44 US: 125) |
| Distribution | Worldwide distribution - US Nationwide distribution and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.