Recall Z-0628-2022 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
TELEFLEX MEDICAL INC
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and syntheti
| Date | Feb 15, 2022 (initiated Jan 11, 2022) |
| Status | Terminated |
| Reason | The firm received reports indicating PTD tip separation during use. |
| Root cause | Process change control |
| Action | Arrow International LLC/Teleflex notified their consignees by letter on 01/11/2022. The letter explained the issue and requested that the consignee cease use and distribution. Distributors were directed to notify their customers. The firm is seeking return of the affected product. The following instructions were provided: Action list number 1 Medical facilities 1. 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 m |
| Quantity | 5530 units |
| Distribution | Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR. |
| 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 |