Formula 418 G56614Recalls & reported problems
Cook Incorporated · Formula 418, Renal Balloon-Expandable Stent · Class 3 · 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 10827002566146), received between Dec 19, 2018 and Dec 19, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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.
Most reported problems
Device problems
- Failure to Advance1
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2018Failure to Advance; Physical Resistance/Sticking
IT WAS REPORTED THAT THE FORMULA 418 RENAL BALLOON-EXPANDABLE STENT WOULD NOT WOULD NOT CROSS THE LESION, AND WHEN IT WAS REMOVED, IT WAS FOUND TO BE STUCK ON THE OUTER SHEATH, MAKING IT UNUSABLE. THE PROCEDURE WAS COMPLETED WITH A NEW STENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8178751 ↗
Other STENT, RENAL devices
- Express® SD Renal/Biliary H74937912618150Boston Scientific Corporation · STENT, RENAL27 reports
- Herculink Elite 1011487-15Abbott Vascular Inc. · STENT, RENAL27 reports
- Herculink Elite 1011487-12Abbott Vascular Inc. · STENT, RENAL24 reports
- Herculink Elite 1011493-18Abbott Vascular Inc. · STENT, RENAL1 death16 reports
- Herculink Elite 1011487-18Abbott Vascular Inc. · STENT, RENAL13 reports
- Herculink Elite 1011499-18Abbott Vascular Inc. · STENT, RENAL13 reports
- Herculink Elite 1011499-15Abbott Vascular Inc. · STENT, RENAL12 reports
- Herculink Elite 1011493-12Abbott Vascular Inc. · STENT, RENAL11 reports
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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