Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Recalled by Arrow International Inc Due to 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arrow International Inc directly.
Affected Products
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC 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
Quantity: 1245 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Arrow International Inc
Arrow International Inc has 431 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report