medical Class I Updated 2021-11-24

Arrow International Inc recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thromboly

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 13F19M0129 13F20B0053 13F20C0595 13F20F0231 13F20G0361 13F20K0632 13F21A0353 13F21C0748 13F21D0721 13F21E0823 13F21F1189
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