Arrow recalls specific 7FR Percutaneous Thrombolytic Devices due to risk of inner lumen detachment causing embolization and delayed treatment. Affected units have specific lot numbers.
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 that may have a detached inner lumen, which could cause embolization and delay critical treatment. This risk affects patients undergoing dialysis procedures.
The inner lumen (orange part) of the device can detach, leading to blood clots blocking blood flow. This may require additional medical intervention and delay life-saving treatment for dialysis patients.
Patients using dialysis treatments with the recalled Arrow Percutaneous Thrombolytic Devices are most at risk. Healthcare providers who use these devices for mechanical declotting are also affected.
Check for the product code PT-65709-WC and lot numbers listed: 13F19J0656 through 13F21F1188. The device is used in dialysis treatments for blood clot removal.
Look for the lot numbers listed: 13F19J0656 through 13F21F1188 on the device packaging.
The inner lumen (orange part) may detach, causing blood clots to block blood flow and requiring additional medical intervention to delay critical treatment.
Check for the product code PT-65709-WC and lot numbers 13F19J0656 through 13F21F1188 on the device packaging.
The recall does not require immediate stoppage; however, affected devices should be checked for the specific lot numbers listed.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0234-2022 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0234-2022 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.
