Arrow International Inc Recall 88796
Description: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC 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
Arrow International Inc Recall 88796 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0234-2022 |
| Event ID | 88796 |
| Event Description | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC 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 |
| Product Type | Devices |
| 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 |
| Quantity | 1918 units |
| Recall 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. |
| Device Classification | 20211124 |
| Device Code Info | Lot Number: 13F19J0656 13F19K0368 13F19K0342 13F20C0596 13F20F0081 13F20F0229 13F20F0509 13F20F0578 13F20G0177 13F20G0566 13F20H0531 13F20J0379 13F20L0514 13F21A0354 13F21C0081 13F21C0749 13F21D0870 13F21E0415 13F21F1188 |
| Center Classification Date | 20211118 |
| Recall Initiation Date | 20210920 |
| Recalling Firm | Arrow International Inc |
| Initial Notification | Letter |
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