Use cautionMedical device recall · FDA · Published September 20, 2021
Arrow Percutaneous Thrombolytic Device Recall: Risk of Embolization
Arrow recalls 7FR Percutaneous Thrombolytic Devices with risk of inner lumen detachment causing embolization. Affected units have specific product codes and lot numbers. Consumers should contact Arrow for details.
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.
Take action
Contact the company
📍Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607
✎ GovInfoNow plain-language explainer
Arrow is recalling certain Percutaneous Thrombolytic Devices due to a risk that the inner lumen (orange part) may detach, leading to embolization and requiring additional medical intervention. This could delay critical treatment for patients with dialysis access issues. Read more at govinfonow.com/recall/61791-arrow-percutaneous-thrombolytic-device-recall-risk-of-embolization.
“Arrow Percutaneous Thrombolytic Device Recall: Risk of Embolization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61791-arrow-percutaneous-thrombolytic-device-recall-risk-of-embolization. Based on FDA recall #Z-0233-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0233-2022%22&limit=1).
The FDA announced on 2021-09-20 that Arrow International Inc. is recalling the Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device due to a detached inner lumen hazard. The agency issued recall number Z-0233-2022 for the Class I voluntary recall.
The FDA said the 7FR Percutaneous Thrombolytic Device (PTD) inner lumen (orange) may detach from the device basket. This defect can result in embolization and retrieval with an additional intervention, causing a consequent delay of therapy.
Context
GovInfoNow's records show ARROW INTERNATIONAL Inc. has 52 other recalls on record since 2017-06-01. Other recent recalls include Arrow Arterial Kits and Trays (2024-07-26), Arrow UltraFlex Intra-Aortic Balloon Catheter Kit (2024-04-29), and ARROW QuickFlash Radial Artery Catheter (2024-02-12). Other recent recalls of similar products include Arrow Hemodialysis Catheter Recall (2026-04-10), Arrow HemoDialysis Kit Recall (2026-04-21), and Arrow VectorFlow Hemodialysis Catheters Recall (2026-04-10).
How to tell if you have this one
Check for product codes PT-65709-W and lot numbers including 13F19M0129 through 13F21F1189. The device is sold under the brand Arrow-Trerotola Over-The-Wire PTD Kit.
Brand
Arrow
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
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
Recall number
Product, codes & lots
Quantity
Z-0231-2022
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; Lot Number: 13F19K0564 13F20C0094 13F20G0284 13F20L0282 13F21A0497 13F21A0718 13X21E0008 13F21F1187
447 units
Z-0232-2022
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; Lot Number: 13F19K0369 13F20A0323 13F20B0139 13F20C0594 13F20F0083 13F20F0230 13F20F0577 13F20H0756 13F20K0849 13F20L0283 13F20M0182 13F21A0498 13F21B0158 13F21C0747 13F21E0555
1245 units
Z-0233-2022
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; Lot Number: 13F19M0129 13F20B0053 13F20C0595 13F20F0231 13F20G0361 13F20K0632 13F21A0353 13F21C0748 13F21D0721 13F21E0823 13F21F1189
1167 units
Z-0234-2022
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; Lot Number: 13F19J0656 13F19K0368 13F19K0342 13F20C0596 13F20F0081 13F20F0229 13F20F0509 13F20F0578 13F20G0177 13F20G0566 13F20H0531 13F20J0379 13F20L0514 13F21A0354 13F21C0081 13F21C0749 13F21D0870 13F21E0415 13F21F1188
1918 units
Based on the official FDA remedy
What to do — step by step
Contact Arrow
Reach out to Arrow International Inc. for specific details about your device and next steps.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0233-2022 (September 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0233-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.