BRITE TIP 5560540LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032015223), received between Jun 14, 2021 and Mar 23, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A CORONARY ANGIOPLASTY, A LONG BRITE TIP GUIDING CATHETER (GC 5F 056 XB 3.5 LBT) WAS REQUESTED BY THE HEMODYNAMICIST, AND ITS DISTAL TIP WAS OBSERVED SPLIT (TORN). THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS NOT USED AS THE DAMAGE WAS EVIDENT AT THE TIME OF OPENING THE PACKAGE. ANOTHER CATHETER WAS REQUESTED FROM THE PHARMACY AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. A RADIAL APPROACH WAS USED. THE VESSEL HAD MILD TORTUOSITY AND NO STENOSIS. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. NEITHER THE PRODUCT NOR ANY OF THE OTHER DEVICES USED WITH IT HAD BEEN RESTERILIZED. THE DEVICE IS EXPECTED TO BE RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13859770 ↗
• MalfunctionDec 15, 2021Crack; Crack

  AS REPORTED, THE TIP OF 5F .056 EXTRA BACK-UP (XB) 3.5 LONG VISTA BRITE TIP GUIDING CATHETER WAS DEFECTIVE. AS A RESULT THE CATHETER WAS CHANGED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN AN INTERVENTIONAL CARDIOLOGY PROCEDURE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WAS RETURNED FOR EVALUATION. AS PER PRODUCT EVALUATION, DURING THE VISUAL INSPECTION, THE UNIT PRESENTED A TORN CONDITION LOCATED APPROXIMATELY AT 6.1 CM FROM DISTAL TIP. DUE THE TORN CONDITION FOUND ON THE UNIT, A SEM ANALYSIS WAS PERFORMED, AND RESULTS SHOWED THAT THE TORN AREA OF THE BODY/SHAFT FROM THE GC 5F 056 XB 3.5 LBT UNIT PRESENTED EVIDENCE OF ELONGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012003 ↗
• InjuryJun 14, 2021Difficult to Remove; Difficult to Remove

  UPON THE REMOVAL OF A 5F .056¿ EXTRA BACK-UP (XB) LONG BRITE TIP (LBT) GUIDING CATHETER, THE GUIDING CATHETER KINKED AND DEFORMED AS IT WAS WITHDRAWN FROM OVER THE SUBCLAVIAN ARCH. THE CATHETER WAS THEN NOT ABLE TO BE WITHDRAWN THROUGH THE SHEATH (UNKNOWN), WHICH LED TO FURTHER DEFORMITY. THIS ISSUE PROVOKED AN INJURY, THE VESSEL DAMAGE N THE RADIAL DUE TO TRAUMA FROM THE REMOVAL OF THE DEFORMED CATHETER. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Perforation of Vessels

  MAUDE report 11991253 ↗