Cook recalls specific Universa Soft Ureteral Stent models due to risk of stiff wire guide tip entering patient during insertion. Affected units have unique product numbers; contact Cook for remedy.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Cook is recalling specific models of Universa Soft Ureteral Stents because the wire guide might be loaded incorrectly, causing the stiff tip to enter the patient instead of the flexible tip. This could lead to injury during medical procedures.
The wire guide may be incorrectly loaded into its holder, causing the stiff part of the wire guide to enter the patient instead of the flexible tip. This could lead to injury during insertion procedures.
Patients undergoing urological procedures who use the recalled stents are most at risk. Healthcare providers who have the affected models in their inventory should check their devices.
Check for product numbers starting with G49887 through G49959 or G53145 through G53726 in the list provided by Cook. The stents are used in medical procedures for urinary tract issues.
Identify the specific product numbers listed in the recall notice to confirm if your stent is affected.
Reach out to Cook directly for instructions on how to handle the recalled stent.
The wire guide may be incorrectly loaded into the holder, causing the stiff tip to enter the patient instead of the flexible tip during insertion.
Check the product numbers listed in the recall notice, which include specific codes like G49887 through G49959 or G53145 through G53726.
Contact Cook directly for instructions on how to handle the recalled stent.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0978-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0978-2020 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.
