BRITE TIP 401511MRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705032000178), received between Apr 14, 2021 and Jan 5, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Detachment of Device or Device Component

  AS REPORTED, THE HEAD OF THE GRAY DILATOR OF TWO 5F (11 CM) .035-INCH BRITE TIP SHEATH INTRODUCERS BROKE OFF. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE NOT INSERTED INTO THE PATIENT AND THE TIPS BROKE OFF ON THE BACK TABLE. BOTH DEVICES WERE FROM THE SAME LOT NUMBER AND WERE USED DURING THE SAME CASE. PER THE ACCOUNT, ADDITIONAL INFORMATION IS NOT AVAILABLE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969174 ↗
• MalfunctionJan 5, 2026Detachment of Device or Device Component

  AS REPORTED, THE HEAD OF THE GRAY DILATOR OF TWO 5F (11 CM) .035-INCH BRITE TIP SHEATH INTRODUCERS BROKE OFF. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE NOT INSERTED INTO THE PATIENT, AND THE TIPS BROKE OFF ON THE BACK TABLE. BOTH DEVICES WERE FROM THE SAME LOT NUMBER AND WERE USED DURING THE SAME CASE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968241 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DILATORS OF TWO 5F 11CM .035-INCH BRITE TIP SHEATH INTRODUCERS FRACTURED DURING INSERTION OVER THE WIRE, AND THE COMPLETE ENDS OF BOTH DILATORS FELL OFF. THERE WAS NO REPORTED PATIENT INJURY. THE DILATOR SEPARATED DURING INSERTION, WITH THE HUB BREAKING OFF OUTSIDE THE PATIENT WHILE THE SHEATH WAS IN PLACE. THE SEPARATED SYSTEM WAS SUCCESSFULLY REMOVED OVER THE WIRE. THE DEVICE HAD BEEN FLUSHED PRIOR TO USE, AND THE VESSEL DILATOR WAS PROPERLY SNAPPED INTO PLACE AT THE HUB. NO DIFFICULTIES WERE ENCOUNTERED DURING THE INSERTION PROCESS. THE PROCEDURE WAS COMPLETED BY CAREFULLY REMOVING THE DEVICE AND INSERTING A 6F SHEATH. NO DAMAGE WAS OBSERVED ON THE DEVICE BEFORE USE, AND NO HARM WAS CAUSED TO THE PATIENT. THE VESSEL AT THE INSERTION SITE EXHIBITED MILD CALCIFICATION AND MILD TORTUOSITY. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768421 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DILATORS OF TWO 5F 11CM .035-INCH BRITE TIP SHEATH INTRODUCERS FRACTURED DURING INSERTION OVER THE WIRE, AND THE COMPLETE ENDS OF BOTH DILATORS FELL OFF. THERE WAS NO REPORTED PATIENT INJURY. THE DILATOR SEPARATED DURING INSERTION, WITH THE HUB BREAKING OFF OUTSIDE THE PATIENT WHILE THE SHEATH WAS IN PLACE. THE SEPARATED SYSTEM WAS SUCCESSFULLY REMOVED OVER THE WIRE. THE DEVICE HAD BEEN FLUSHED PRIOR TO USE, AND THE VESSEL DILATOR WAS PROPERLY SNAPPED INTO PLACE AT THE HUB. NO DIFFICULTIES WERE ENCOUNTERED DURING THE INSERTION PROCESS. THE PROCEDURE WAS COMPLETED BY CAREFULLY REMOVING THE DEVICE AND INSERTING A 6F SHEATH. NO DAMAGE WAS OBSERVED ON THE DEVICE BEFORE USE, AND NO HARM WAS CAUSED TO THE PATIENT. THE VESSEL AT THE INSERTION SITE EXHIBITED MILD CALCIFICATION AND MILD TORTUOSITY. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768398 ↗
• MalfunctionMay 9, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE TIP OF A 5F 11CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) WAS DAMAGED DURING THE PUNCTURE OF THE ARTERY. AN UNKNOWN CSI WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE IS NOW BEING RETURNED. ADDENDUM: THE BRITE TIP CSI WAS RETURNED WITH THE DISTAL TIP FRAYED/TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993369 ↗
• MalfunctionFeb 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F 11CM BRITE TIP SHEATH SNAPPED OFF INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN A FEMORAL BYPASS GRAFT PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721536 ↗
• MalfunctionNov 12, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE DISTAL TIP OF THE 5F 11 CM BRITE TIP SHEATH INTRODUCER WAS FOUND FRAYED WHILE REMOVING THE SHEATH FROM THE PACKAGE AND BEFORE GOING INTO THE PATIENT. ANOTHER 5F BRITE TIP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117339 ↗
• MalfunctionOct 18, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE TIP OF A 5F BITE TIP CATHETER SHEATH INTRODUCER (CSI) WAS DAMAGED WHEN OPENED. UPON REVIEWING THE SHEATH, THERE IS A "LITTLE LIP AT THE DISTAL END BY THE RADIOPAQUE MARKER." THE SHEATH WAS NOT USED BECAUSE IT WAS NOTICED TO BE DAMAGED. ANOTHER 5F BRITE TIP SHEATH WAS OBTAINED AND WENT IN FINE. THERE WAS NO REPORT PATIENT INJURY. THE DEVICE WAS STORED AS PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: AS PER VISUAL ANALYSIS DURING THE PRODUCT EVALUATION, THE CANNULA SHEATH INTRODUCER WAS OBSERVED FRAYED/SPLIT/TORN DAMAGED ON THE DISTAL TIP OF THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629386 ↗
• MalfunctionOct 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F BRITE TIP CSI WAS INTRODUCED INTO THE PATIENT; HOWEVER, WHEN REMOVING THE DILATOR, THE HEMOSTATIC VALVE WAS PULLED OFF. THIS CAUSED BLOOD TO PULSATE OUT OF THE SHEATH. THE PHYSICIAN SWITCHED TO A 6F BRITE TIP SHEATH AND THE CASE WAS COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE TO THE PACKAGE. THE PRODUCT WAS STORED IN THE LAB PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THE DEVICE WAS PREPPED PER THE IFU WITHOUT DIFFICULTY. THE SHEATH WAS NOT TORQUED AGAINST RESISTANCE AND NO EXCESS FORCE WAS USED OR NEEDED. THERE AS NO DIFFICULTY TRACKING THE CSI THROUGH THE VASCULATURE. THERE WAS NO STENT NOTED TO BE NEAR THE PUNCTURE SITE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689474 ↗
• MalfunctionApr 14, 2021Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, AN EXOSEAL (UNKNOWN) VASCULAR CLOSURE DEVICE (VCD) WAS INSERTED INTO A 5F 11CM BRITE TIP SHEATH INTRODUCER; HOWEVER, THE DISTAL END OF THE BRITE TIP GOT FRAYED. IT WAS THEN REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING INTO THE PATIENT. EXCESS FORCE WAS NOT USED DURING INSERTION. THE PROCEDURE WAS COMPLETED BY MANUAL PRESSURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS ALREADY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11663035 ↗