Arrow recalls specific Percutaneous Thrombolytic Device kits (PTD) with potential tip separation during use. Affected units include certain lot numbers and model codes. Stop using immediately if you own these kits.
The firm received reports indicating PTD tip separation during use.
Arrow is recalling Percutaneous Thrombolytic Device kits that may separate during use, potentially causing complications. This recall affects specific lot numbers and model codes used in dialysis treatments.
The device tip can separate during use, which may lead to complications in dialysis treatments. This separation could cause blockages or damage to the vascular access site.
Patients using dialysis treatments with the affected Arrow PTD kits are most at risk. Healthcare providers who use these kits for mechanical declotting of vascular access may also be affected.
Check for the model code PT-65709-C with specific lot numbers listed in the recall notice. The affected kits include units with lot numbers starting with 13F19M through 13F21F.
If you have the affected Arrow PTD kits, stop using them right away to prevent potential tip separation.
The recalled device is the Arrow-Trerotola Over-The-Wire PTD Kit, model code PT-65709-C with specific lot numbers listed in the recall notice.
Check the lot number on your device, which starts with 13F19M through 13F21F, and matches the specific model code PT-65709-C as listed in the recall notice.
The recall notice does not specify a return process, so contact Arrow directly for instructions on disposal or replacement.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0625-2022 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0625-2022 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.
