Arrow International Inc: Medical Device Recall in 2021 - (Recall #: Z-0231-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: September 20, 2021

Date Posted: November 24, 2021

Recall Number: Z-0231-2022

Event ID: 88796

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.

Status: Terminated

Product Quantity: 447 units

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

Voluntary or Mandated:

Voluntary: Firm initiated