Z-0231-2022 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 24, 2021
- Initiation Date
- September 20, 2021
- Termination Date
- October 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 447 units
Product Description
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-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
Reason for Recall
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.
Distribution Pattern
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
Code Information
Lot Number: 13F19K0564 13F20C0094 13F20G0284 13F20L0282 13F21A0497 13F21A0718 13X21E0008 13F21F1187