Formula 418 G56609Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002566092), received between Oct 25, 2024 and Oct 25, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature Separation” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Premature Separation; Premature Separation

  AS REPORTED, DURING A PROCEDURE INVOLVING IMPLANTATION OF A STENT WITHIN THE RENAL ARTERY, A FORMULA 418 RENAL BALLOON-EXPANDABLE STENT SLIPPED OFF THE BALLOON. THE DEVICE WAS LOADED THROUGH ANOTHER MANUFACTURER¿S 6-FRENCH GUIDE AND ADVANCED NEAR THE RENAL ARTERY. THE INSERTION TOOL WAS NOT USED TO INSERT THE DEVICE INTO THE GUIDE/SHEATH; HOWEVER, A LARGE TUOHY-BORST ADAPTER WAS USED DURING INSERTION. THE STENT WAS NOT MOISTENED WITH HEPARINIZED SALINE AND GAUZE WAS NOT USED TO MOISTEN THE STENT. THE REFERENCE VESSEL DIAMETER WAS APPROXIMATELY SIX MILLIMETERS, AND THE LESION WAS LESS THAN FIVE CENTIMETERS LONG. THE ANATOMY WAS TORTUOUS, AND THE LESION WAS CALCIFIED AND NINETY PERCENT STENOSED. AS THE USER ATTEMPTED TO MANEUVER THE STENT THROUGH THE STENOSED LESION, THE STENT SLIPPED OFF THE BALLOON. THE PHYSICIAN WAS ABLE TO QUICKLY CAPTURE AND RETRIEVE THE STENT USING ANOTHER MANUFACTURER¿S BALLOON, AND THE STENT WAS THEN DEPLOYED AND IMPLANTED IN THE RENAL ARTERY AS INTENDED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537816 ↗