Arrow recalls specific 7FR Percutaneous Thrombolytic Devices due to risk of inner lumen detachment causing embolization and delayed therapy. Affected units include Lot Numbers 13F19K0564 through 13F21F1187.
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 Thromb: 7FR devices that could detach internally, leading to embolization and requiring additional medical procedures. This risk may delay critical treatments for patients with dialysis access.
The inner lumen (orange tube) can detach from the device basket 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 Kit (7FR) are most at risk. Healthcare providers who use these devices for mechanical declotting may also be affected.
Check for the product code PT-12709-WC and Lot Numbers 13F19K0564 through 13F21F1187 on the device packaging or label.
Look for Lot Numbers 13F19K0564 through 13F21F1187 on the device packaging or label.
The inner lumen (orange tube) can detach from the device basket, causing blood clots to travel and requiring additional medical procedures, which may delay critical treatment.
Check for the product code PT-12709-WC and Lot Numbers 13F19K0564 through 13F21F1187 on the device packaging or label.
The recall does not specify a remedy, so contact Arrow International for further instructions.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0231-2022 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0231-2022 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.
