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
Reported: November 24, 2021 Initiated: September 20, 2021 #Z-0233-2022
Product 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
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.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 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
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Arrow International Inc. Units affected: 1167 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 24, 2021. Severity: Critical. Recall number: Z-0233-2022.
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