Cook Inc. recalls Formula 418 Renal Balloon-Expandable Stents (lot 10153876) due to potential dislodgement during deployment, which may require additional intervention. Learn if your stent is affected and what to do.
The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location.
Cook Inc. is recalling a specific lot of renal stents (lot 10153876) because they may dislodge from the delivery system before being properly deployed. This could lead to longer procedures and additional steps to remove the stent from an unintended location.
The stent may dislodge from the balloon delivery system before deployment, causing it to be placed in an unintended location. This requires additional medical intervention to remove the stent, increasing procedural time and complexity.
Patients who received the specific lot (10153876) of Formula 418 Renal Balloon-Expandable Stents during procedures. Medical professionals using this stent for treatments are most at risk.
Check the lot number on the stent packaging. The affected lot is 10153876. This stent is used in renal procedures and has a specific order number (GPN) G56611.
Look for the lot number 10153876 on the stent packaging or documentation.
The recall is for a specific lot (10153876) that may dislodge during deployment. Properly deployed stents from other lots are not affected.
Check the lot number on your stent packaging. If it is 10153876, contact Cook Inc. for further instructions.
The stent may dislodge from the balloon delivery system before deployment, leading to unintended placement and requiring additional medical intervention.
We’ve drafted a message you can send Cook Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-1940-2020 — Cook Inc. Cook Inc. Hello, I own a Cook Inc. that is covered by recall Z-1940-2020 from Cook Inc.. 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.
