Cook Medical recalls ureteral stent sets with incorrect material that may break during use. Affected models include 7.0Fr. 22-32cm for ESWL procedures. Contact for return or replacement.
Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
Cook Medical is recalling ureteral stent sets that were made with the wrong material. This could make the stent stiffer and more likely to break, which might cause injury during medical procedures.
The stent was manufactured with incorrect material, making it stiffer than intended. This stiffness increases the risk of the stent breaking or fragmenting during use, which could cause injury to the patient.
Patients receiving ureteral stent procedures through extracorporeal shock wave lithotripsy (ESWL) are most at risk. The affected stents are used in specific medical treatments for kidney stones.
Check for the model number 7.0Fr. 22-32cm on the stent packaging. Affected units have lot numbers 13024536, 13089895, or NS13089897. The stents are used in ESWL procedures for kidney stones.
Look for the model number 7.0Fr. 22-32cm on the stent packaging or label.
Reach out to Cook Medical for instructions on returning or replacing the stent.
The stent was manufactured with incorrect material, which makes it stiffer and more likely to break during use.
Check the model number and lot numbers to see if your stent is affected. Contact Cook Medical for return or replacement instructions.
The recall indicates a risk of breakage due to material issues, but the stent is safe if used as intended with proper medical supervision.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0960-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0960-2021 from Cook. 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.
