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.
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.
The inner lumen (orange part) of the device can detach during use, causing blood clots to travel to other parts of the body. This may require additional medical procedures and delay critical treatment for dialysis patients.
Patients using dialysis access devices with the recalled Arrow Percutaneous Thrombolytic Devices are most at risk. Healthcare providers who use these devices for mechanical declotting may also be affected.
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.
Reach out to Arrow International Inc. for specific details about your device and next steps.
The inner lumen (orange part) may detach, causing embolization and requiring additional medical intervention to treat blood clots.
Check for product code PT-65709-W and lot numbers 13F19M0129 through 13F21F1189.
The recall does not specify an immediate stop-use order; contact Arrow for guidance.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0233-2022 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0233-2022 from Arrow. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
