Formula 418 G42971Recalls & reported problems
Cook Incorporated · Formula 418 Biliary Stent System · Class 2 · Implant
All models of Formula 418 (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002429717), received between Jan 2, 2024 and Jan 2, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2024Material Rupture; Material Rupture
ADDITIONAL INFORMATION WAS RECEIVED 03JAN2024. THE ANATOMY WAS STENOSED AND CALCIFIED, AND THE LESION WAS NINETY-PERCENT OCCLUDED. THE LESION WAS BALLOONED WITH A COOK ANGIOPLASTY BALLOON PRIOR TO USE OF THE COMPLAINT DEVICE. THE ANGIOPLASTY BALLOON WAS REMOVED INTACT. NEGATIVE PRESSURE WAS MAINTAINED UPON REMOVAL OF THE COMPLAINT DEVICE, WHICH WAS REMOVED INTACT WITH AN UNSPECIFIED COOK 6-FRENCH SHEATH, AS THE COMPLAINT DEVICE WAS STUCK IN THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18428380 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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