Arrow recalls PTD Set (PTD) kits with specific lot numbers due to reported tip separation during use. Affected units may cause injury during dialysis procedures.
The firm received reports indicating PTD tip separation during use.
Arrow is recalling PTD Sets (Percutaneous Thrombolytic Devices) with certain lot numbers because they can separate during use. This separation risk could lead to injury during dialysis treatments.
The device's tip can separate during use, which may cause injury to the patient or damage to the dialysis system. This separation could occur during mechanical declotting procedures for arterio-venous fistulae or dialysis grafts.
Healthcare professionals using the device for dialysis treatments are most at risk. Patients with kidney failure who require dialysis may be affected if they use the recalled device.
Check the lot number on the device packaging. The affected units have specific lot numbers listed in the recall notice, including 13F20A0286 through 13F21L0898.
Look for the lot number on the device packaging to determine if it is in the affected list.
If the device is affected, contact Arrow Medical for further instructions.
The PTD Set (Percutaneous Thrombolytic Device) is used for mechanical declotting of arterio-venous fistulae and dialysis grafts during dialysis treatments.
Check the lot number on the device packaging. Affected units have specific lot numbers listed in the recall notice, including 13F20A0286 through 13F21L0898.
If your device is affected, contact Arrow Medical for further instructions. Do not use the device until you receive guidance.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0629-2022 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0629-2022 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.
