Z-0232-2022Class I

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR

Name: Z-0232-2022 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR
Creator: Arrow International Inc
Published: 2021-09-20
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2021-09-20 / Terminated

FDA source

Arrow International Inc began a recall of Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device... on 2021-09-20. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0232-2022
Classification: Class I
Status: Terminated
Initiated: 2021-09-20
Posted: 2021-11-18
Terminated: 2023-10-05
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC 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 code: DXE Catheter, Embolectomy
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.
FDA root cause: Unknown/Undetermined by firm
Action: 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 [email protected]. 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: [email protected].
Quantity in commerce: 1245 units
Distribution: 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
Product codes and lots: Lot Number: 13F19K0369 13F20A0323 13F20B0139 13F20C0594 13F20F0083 13F20F0230 13F20F0577 13F20H0756 13F20K0849 13F20L0283 13F20M0182 13F21A0498 13F21B0158 13F21C0747 13F21E0555

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0232-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0231-2022	Class I	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0232-2022	Class I	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0233-2022	Class I	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0234-2022	Class I	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18

Product code DXE

K011056Class IIArrow-Trerotola Percutaneous Thrombolytic Device or PtdArrow Intl., Inc. / cleared 2001-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)