—#189569

Product

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-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

FDA product code: DXE — Catheter, Embolectomy
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K011056
Affected lot / code info: Lot Number: 13F19J0656 13F19K0368 13F19K0342 13F20C0596 13F20F0081 13F20F0229 13F20F0509 13F20F0578 13F20G0177 13F20G0566 13F20H0531 13F20J0379 13F20L0514 13F21A0354 13F21C0081 13F21C0749 13F21D0870 13F21E0415 13F21F1188

Why it was 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.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Arrow International, a subsidiary of Teleflex issued an "URGENT - FIELD SAFETY NOTICE" consignee notification letter on 20th Sept 2021 via FedEx 2-day mail to medical facilities and distributors. Letter states reason for recall, health risk and action to take: We request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately. 2. If you do not have stock in scope of this FSCA mark the according checkbox on the Acknowledgement Form (Appendix 1) and return the form to the fax number or e-mail address mentioned below. 3. If you do have stock in scope of this FSCA, complete the Acknowledgement Form (Appendix 1) and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. Distributors 1. Provide this field safety notice to all customers who have received product in scope of this FSCA. Your customer is then required to complete the Acknowledgement Form and return to you. Should you require any further information or support concerning this issue, please contact: Customer Service Telephone: 1-866-396-2111; FAX: 1-855-419-8507 or E-mail: Recalls@teleflex.com.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

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

Timeline

Recall initiated: 2021-09-20
Posted by FDA: 2021-11-18
Terminated: 2023-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189569. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.