Formula 418 G42973Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002429731), received between Jan 15, 2019 and May 5, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF A STENT WITHIN THE ILIAC ARTERY, A FORMULA 418 BILIARY BALLOON EXPANDABLE STENT BECAME STUCK IN THE PATIENT. THE WIRE GUIDE LUMEN WAS FLUSHED, AND A WIRE WAS PLACED ACROSS THE LESION. IT IS UNKNOWN IF THE STENT WAS MOISTENED WITH HEPARINIZED SALINE. THE INSERTION TOOL WAS NOT USED, NOR WAS A TUOHY-BORST ADAPTER. THE USER WAS ATTEMPTING TO PLACE THE BILIARY STENT IN THE ILIAC ARTERY USING AN UNKNOWN INFLATION DEVICE; HOWEVER, IT WOULD NOT EXPAND AND WAS UNABLE TO BE REMOVED FROM AN UNKNOWN 7 FRENCH SHEATH. VESSEL SPASMS WERE NOT NOTED. THE STENT REMAINED ON THE DEPLOYMENT SYSTEM, AND THE PATIENT WAS TRANSFERRED TO A LOCAL HOSPITAL FOR SURGICAL REMOVAL. THE UNDEPLOYED STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT, WHO IS REPORTEDLY DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776713 ↗
• MalfunctionAug 11, 2020Difficult to Remove; Stretched; Detachment of Device or Device Component; Difficult to Remove; Stretched; Detachment of Device or Device Component

  UPON RETURN OF THE COMPLAINT DEVICE, AN UNSPECIFIED COOK FLEXOR SHEATH WAS ALSO RETURNED AND WAS NOTED TO BE SEPARATED. THE SEPARATED SHEATH WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). NO OTHER INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10390724 ↗
• InjuryMar 16, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  ADDITIONAL INFORMATION RECEIVED 20MAR2020. THE STENT WAS SUCCESSFULLY PLACED. THE MARKER BAND REMAINED IN PLACE.

  Patient problems: No Code Available

  MAUDE report 9835164 ↗
• InjuryJan 22, 2019Unintended Movement; Unintended Movement

  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 8266521 ↗
• MalfunctionJan 15, 2019Unintended Ejection; Unintended Ejection

  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 8248314 ↗