Use cautionMedical device recall · FDA · Published April 15, 2020
Cook Formula 418 Stent Recall: Risk of Dislodgement During Deployment
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.
Take action
Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook Formula 418 Stent Recall: Risk of Dislodgement During Deployment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65399-cook-formula-418-stent-recall-risk-of-dislodgement-during-deployment. Based on FDA recall #Z-1940-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1940-2020%22&limit=1).
Cook Inc. recalled Formula 418 Renal Balloon-Expandable Stents on April 15, 2020, after complaints indicated stents could dislodge from their delivery systems, according to the FDA. The agency announced the Class II recall of 10 units distributed in Ohio, Iowa, Virginia, North Carolina, and Canada.
How to tell if you have it
Brand: Cook Inc.
Product: Formula 418 Renal Balloon-Expandable Stent
RPN: FOR418-18-80-6-12
Order Number (GPN): G56611
Lot number: 10153876
The hazard
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.
Context
GovInfoNow's records show Cook Inc. has issued 38 other recalls since July 31, 2017. Recent Cook recalls include the Nov. 12, 2021 Flexor Check-Flo Introducer Ansel Modification for mislabeling risk and the Oct. 13, 2021 Skinny Needle with Chiba Tip Recall due to black debris.
How to tell if you have this one
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.
Brand
Cook Inc.
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Stent Lot Number
Look for the lot number 10153876 on the stent packaging or documentation.
Where it went and when
Where it was distributed
Distributed in 4 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to OH, IA, VA, and NC. Foreign distribution to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Iowa, North Carolina, Ohio, Virginia.
Recall timeline
FDA terminated this recall 4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1940-2020 (April 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1940-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.