Formula G56958Recalls & reported problems
William Cook Europe ApS · Formula 414 Rx, Renal Balloon-Expandable Stent · Class 3 · Implant
Data updated Oct 13, 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 10827002569581), received between Apr 4, 2017 and Apr 4, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).
1 other recall cover devices cleared under the same FDA submission (P100028); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2017Detachment Of Device Component; Detachment Of Device Component
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "ATTEMPTING TO DEPLOY AN EXPANDABLE BALLOON IN THE RIGHT RENAL ARTERY. WHEN ADVANCING THE FORMULA STENT INTO THE RENAL IT PROLAPSED. THE STENT WAS REMOVED FROM THE GUIDE CATHETER AND IT WAS NOTED THAT THE STENT WAS NO LONGER MOUNTED ON THE BALLOON DELIVERY SYSTEM. EVERYTHING WAS REMOVED AND THE STENT WAS FOUND INSIDE THE GUIDE CATHETER AFTER FLUSHING IT WITH SALINE. THE CASE WAS ABORTED, REASON UNKNOWN." PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6455738 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P100028. One submission often covers many models, so check the product and lot details in each record.
- Z-1940-2020 · Apr 15, 2020 · TerminatedFormula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuratio
Other STENT, RENAL devices
- Herculink Elite 1011487-15Abbott Vascular Inc. · STENT, RENAL27 reports
- Express® SD Renal/Biliary H74937912618150Boston Scientific Corporation · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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