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 Recalled by TELEFLEX MEDICAL INC Due to The firm received reports indicating PTD tip separation...
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 TELEFLEX MEDICAL INC directly.
Affected Products
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
Quantity: 676 units
Why Was This Recalled?
The firm received reports indicating PTD tip separation during use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About TELEFLEX MEDICAL INC
TELEFLEX MEDICAL INC has 32 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report