Formula G56969Recalls & reported problems
William Cook Europe ApS · Formula 414 Rx, Renal Balloon-Expandable Stent · Class 3 · Implant
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 10827002569697), received between Mar 15, 2018 and Mar 15, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Difficult to Advance1
Patient problems
- Calcium Deposits/Calcification1
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2018Difficult to Advance; Difficult to Advance
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THEY WERE ABLE TO TRACK A COOK .014 ROADRUNNER AND WERE ABLE TO PASS TWO 14 LP COOK BALLOONS TO PREDILATE THE VESSEL. WHEN THEY WENT IN WITH THE BALLOON EXPANDABLE STENT, IT WOULD NOT PASS. THIS WAS THE CASE FIRST FOR THE 5 X 20 AND THEN FOR THE 5 X 16. NEITHER WOULD PASS. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH A BOSTON SCIENTIFIC BALLOON EXPANDABLE STENT. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE
Patient problems: Calcium Deposits/Calcification; Stenosis
MAUDE report 7340668 ↗
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
- 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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