Formula 418 G56611Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002566115), received between May 15, 2019 and Nov 25, 2020 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (7 reports).
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
- Premature Separation7
Patient problems
- No Consequences Or Impact To Patient5
- Bradycardia1
- Low Blood Pressure/ Hypotension1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2020Premature Separation; Premature Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10906053 ↗MalfunctionOct 21, 2020Premature Separation; Premature Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10710433 ↗MalfunctionMar 13, 2020Premature Separation; Premature Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9831396 ↗MalfunctionFeb 20, 2020Premature Separation; Premature Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9732390 ↗InjuryFeb 20, 2020Premature Separation; Premature Separation
ADDITIONAL INFORMATION RECEIVED 11JUN2020. THE DEVICES WERE USED TO ATTEMPT TO STENT A RIGHT-VENTRICLE-TO-PULMONARY-ARTERY CONDUIT PREVIOUSLY CREATED IN A NORWOOD OPERATION DUE TO A HISTORY OF HYPOPLASTIC LEFT HEART SYNDROME.
Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; No Consequences Or Impact To Patient
MAUDE report 9732368 ↗MalfunctionFeb 17, 2020Premature Separation; Premature Separation
ADDITIONAL INFORMATION RECEIVED 19MAR2020. THE INSERTION TOOL WAS NOT USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9716658 ↗InjuryMay 15, 2019Premature Separation; Premature Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 8613037 ↗
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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