Arrow International Inc Recall 88796
Description: 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
Arrow International Inc Recall 88796 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0233-2022 |
| Event ID | 88796 |
| Event Description | 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 |
| 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 | 1167 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: 13F19M0129 13F20B0053 13F20C0595 13F20F0231 13F20G0361 13F20K0632 13F21A0353 13F21C0748 13F21D0721 13F21E0823 13F21F1189 |
| Center Classification Date | 20211118 |
| Recall Initiation Date | 20210920 |
| Recalling Firm | Arrow International Inc |
| Initial Notification | Letter |
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