Formula 418 G56625Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002566252), received between May 6, 2022 and May 6, 2022 — 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.

• MalfunctionMay 6, 2022Premature Separation; Premature Separation

  AS REPORTED, A FORMULA 418 RENAL BALLOON-EXPANDABLE STENT DETACHED FROM THE BALLOON. THE ACCESS SITE WAS THE RIGHT FEMORAL VEIN (RFV) AND THE TARGET SITE WAS THE LEFT PULMONARY ARTERY (LPA). THE BALLOON AND STENT WERE INSERTED THROUGH A 5 FRENCH COOK SHEATH (WITHOUT ROTATING) AND UPON EXITING THE SHEATH WITHIN THE INFERIOR VENA CAVA, THE USER NOTICED THAT THE STENT WAS NOT CENTERED ON THE BALLOON. THE USER THEN REMOVED THE BALLOON CATHETER THROUGH THE SHEATH. HOWEVER; THE STENT CAME OFF THE BALLOON AND BECAME STUCK IN THE SHEATH DURING REMOVAL. THE SHEATH AND STENT WERE REMOVED AND REPLACED WITH A NEW SHEATH AND STENT TO CONTINUE THE PROCEDURE. THE ANATOMY WAS NOT TORTUOUS AND THE BALLOON WAS NEVER INFLATED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310664 ↗