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Recall Observatory FDA recall evidence

Device product

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

Z-0231-2022

September 20, 2021

Class I

Product summary

Firm
Arrow International Inc
Event
Event 88796
Status
Terminated
Classification
Class I
Quantity
447 units
Official record key
device-enforcement:Z-0231-2022

Official wording

Reason: 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.

Code information: Lot Number: 13F19K0564 13F20C0094 13F20G0284 13F20L0282 13F21A0497 13F21A0718 13X21E0008 13F21F1187

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.