Recall Z-0233-2022 ยท DXE Catheter, Embolectomy
Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
| Date | Nov 18, 2021 (initiated Sep 20, 2021) |
| Status | Terminated |
| Reason | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy. |
| Root cause | Unknown/Undetermined by firm |
| Action | Arrow International, a subsidiary of Teleflex issued an "URGENT - FIELD SAFETY NOTICE" consignee notification letter on 20th Sept 2021 via FedEx 2-day mail to medical facilities and distributors. Letter states reason for recall, health risk and action to take: We request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately. 2. If you do not have stock in scope of this FSCA mark the according checkbox on the Acknowledgement Form (Appendix 1) and return the form to the fax number or e-mail |
| Quantity | 1167 units |
| Distribution | Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE CA CL CZ DE ES FR IL IT KR PH SA TR TW UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011056 | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD Arrow Intl., Inc., Oct 24, 2001 |