BRITE TIP 401611MRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705032000239), received between Feb 6, 2019 and Jul 7, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THERE WAS A POSSIBLE DEFECT IN THE SIDE PORT TUBING OF THE 6F 11CM CORDIS SHEATH. THE TUBING OF THE SHEATH WAS ATTACHED TO A PRESSURE BAG, AND THE TUBING DISLODGED FROM THE SHEATH WHILE REMOVING THE GAUZE AND TEGADERM DRESSING. THE SHEATH WAS STILL IN THE PATIENT, AND THERE WAS BLEEDING NOTED FROM THE BROKEN SIDE PORT. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ONE IMAGE WAS PROVIDED, AND IT SHOWS A CATHETER SHEATH INTRODUCER WITH A VISIBLE SEPARATION BETWEEN THE SIDE PORT EXTENSION AND THE HUB. BLOOD IS PRESENT WITHIN THE SIDE PORT TUBING, INDICATING THAT THE SYSTEM HAD BEEN IN USE PRIOR TO THE DISCONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409327 ↗
• MalfunctionJul 1, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A 6F 11CM BRITE TIP SHEATH INTRODUCER HAD A SIGNIFICANT DEFECT AT THE TIP OF THE SHEATH. THERE WERE NO REPORTS OF PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PER PE FINDINGS, THE SHEATH WAS RECEIVED WITH THE DISTAL TIP TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378103 ↗
• MalfunctionNov 7, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE 6F 11CM BRITE TIP SHEATH INTRODUCER WAS USED. HOWEVER, IT COULD NOT BE INSERTED. WHEN IT WAS REMOVED, THE TIP OF THE SHEATH WAS FRAYED. THEREFORE, IT WAS REPLACED WITH A NEW DEVICE AND THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS AN EVT CASE. AFTER THE RIGHT FEMORAL PUNCTURE, THE BRITE TIP SHEATH WAS USED. AFTER EVT WAS COMPLETED, IT WAS CONFIRMED THAT THERE WERE NO COMPLICATIONS AT THE PUNCTURE SITE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631029 ↗
• MalfunctionSep 11, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE 6F 11CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) COULD NOT BE INSERTED TO THE FEMORAL ARTERY. THE DOCTOR TRIED INSERTING IT IN AND OUT SEVERAL TIMES, BUT THE TIP GOT FRAYED. SO, IT WAS REMOVED. THEREFORE, IT WAS REPLACED WITH A NEW DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT ANY TROUBLE AT THE PUNCTURE SITE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195159 ↗
• MalfunctionSep 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, A PUNCTURE WAS MADE AND A 6F STRAIGHT BRITE TIP CATHETER SHEATH INTRODUCER (CSI) WAS ATTEMPTED TO BE INSERTED BUT INSERTION WAS DIFFICULT DUE TO A GAP BETWEEN A DILATOR AND THE SHEATH. THE PHYSICIAN TRIED MANY TIMES REPEATEDLY AND THE DISTAL TIP GOT FRAYED AND INSERTION WAS IMPOSSIBLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE RIGHT INGUINAL REGION. THE DEVICE WAS STORED, HANDLED, AND PREPPED AS PER INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS INSPECTED PRIOR TO USE FOR DAMAGES AND THERE WERE NO DAMAGES NOTED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE ACCESS VESSEL WAS SEVERELY CALCIFIED. THERE WAS MILD VESSEL TORTUOSITY AND THERE WAS 80 PERCENT OF STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457751 ↗
• MalfunctionJun 24, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A 6F 11CM BRITE TIP SHEATH WAS UNABLE TO BE INSERTED SMOOTHLY. THE USER REMOVED THE SHEATH AND HAD NOTICED THAT THE DISTAL END WAS FRAYED. THE DEVICE WAS REPLACED WITH ANOTHER UNKNOWN SHEATH AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806697 ↗
• MalfunctionMar 26, 2021Material Frayed; Material Frayed

  AS REPORTED, A 6F 11CM STRAIGHT (STR) BRITE TIP SHEATH INTRODUCER WAS USED WITH AN UNKNOWN EXOSEAL DEVICE; HOWEVER, THE DISTAL END GOT FRAYED. THERE WAS NO REPORTED PATIENT INJURY. THE SHEATH WAS NOT USED IN THE PROCEDURE AND THEREFORE, REPLACED WITH A NEW UNKNOWN SHEATH AND HEMOSTASIS WAS ACHIEVED. THE ACCESS SITE WAS MODERATELY TORTUOUS. THE SHEATH WAS NOT USED IN THE PROCEDURE PRIOR TO CLOSING WITH THE EXOSEAL. THE DEVICE WAS HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE PACKAGING. THERE WERE NO DAMAGES TO THE DEVICE PACKAGING. NO EXCESSIVE FORCE WAS USED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575238 ↗
• MalfunctionDec 10, 2020Crack; Crack

  AS REPORTED, THE DISTAL END OF A 6F 11CM STRAIGHT (STR) BRITE TIP SHEATH INTRODUCER WAS FRACTURED. THE DAMAGE WAS NOTICED AFTER USE. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION HAD LITTLE CALCIFICATION. THERE WAS OVER FIFTY PERCENT STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS SAFELY STORED. THE PRODUCT WAS STORED, HANDLED AND PREPPED ACCORDING TO 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. THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WAS NO RESISTANCE ADVANCING THE PRODUCT TO THE LESION. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10988387 ↗
• MalfunctionOct 28, 2020Material Frayed; Material Frayed

  AS REPORTED, THE 6F 11CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) COULD NOT BE INSERTED AND ITS TIP GOT FRAYED. THEREFORE, IT WAS REPLACED WITH A NEW UNKNOWN SHEATH INTRODUCER AND IT COULD BE INSERTED. THE STENOTIC LESION OF LEFT ILIAC ARTERY WAS TREATED, AND THE PROCEDURE WAS COMPLETED WITH MANUAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS ATTEMPTED TO BE INSERTED FROM LEFT FEMORAL ARTERY AND RETROGRADE APPROACH WAS MADE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS BECAUSE IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10747452 ↗
• MalfunctionMar 17, 2020Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  A 6F 11CM STRAIGHT (STR) BRITE TIP CATHETER SHEATH INTRODUCER (CSI) WAS ATTEMPTED TO BE USED WITH AN EXOSEAL VASCULAR CLOSURE DEVICE (VCD) HOWEVER, IT IS DIFFICULT TO INSERT. THEREFORE, IT WAS REMOVED AND CONFIRMED THAT THE DISTAL END HAD A CUT. THERE WAS A NEW SHEATH INSERTED, THE SAME WIRE WAS NOT USED WITH THE SECOND SHEATH AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE ILIAC ARTERY. THE DEVICE WAS PREPARED NORMALLY AS PER INSTRUCTION FOR USE (IFU). THE PRODUCT LOOKED NORMAL WHEN TAKEN FROM ITS PACKAGING. THE DEVICE WAS APPEARED NORMAL BEFORE THE PROCEDURE. THERE WAS NO EXCESSIVE FORCE USED AND NO DIFFICULTY FLUSHING THE DEVICES. THERE WAS NO DIFFICULTY ASSEMBLING THE DEVICES. A NON-CORDIS GUIDEWIRE WAS USED IN THE PROCEDURE AND WAS NOT KINKED OR BENT. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS SINCE IT WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844832 ↗
• MalfunctionMar 8, 2019Material Frayed; Material Frayed

  AS REPORTED, THE DISTAL END OF A BRITE TIP SHEATH GOT FRAYED AFTER IT WAS INSERTED. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW BRITE TIP SHEATH TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE ILIAC ARTERY. THE VESSEL LEVEL OF ANGULATION, CALCIFICATION AND TORTUOSITY IS NONE. THE VESSEL LEVEL OF STENOSIS ID 100%. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. THE DEVICE WAS NOT RESTERILIZED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. AN IPSILATERAL APPROACH WAS MADE. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO EXCESS FORCE USED DURING INSERTION. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED DUE TO PATIENT¿S INFECTIOUS DISEASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8404733 ↗
• MalfunctionFeb 6, 2019Material Frayed; Difficult to Insert; Material Frayed; Difficult to Insert

  AS REPORTED, AN ATTEMPT TO INSERT AN SI BRITE TIP SHEATH (6F 11CM STR) INTO THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS UNSUCCESSFUL AND THE DISTAL TIP OF THE SHEATH BECAME FRAYED. A SECOND SI BRITE TIP SHEATH (6F 11CM STR) WAS OPENED AND INSERTION WAS ATTEMPTED AGAIN WITH THE SAME RESULTS. A NON-CORDIS SHEATH WAS OPENED AND WAS ABLE TO BE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A LITTLE CALCIFICATION REPORTED AT THE INSERTION SITE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE CLINICALLY USED. THE DEVICE HAS BEEN DISCARDED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE PACKAGE. THE DEVICES WERE STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPPED PER THE IFU. THERE WAS NO DAMAGE NOTED TO THE DEVICES BEFORE ATTEMPTING INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8312781 ↗
• MalfunctionFeb 6, 2019Material Frayed; Difficult to Insert; Material Frayed; Difficult to Insert

  AS REPORTED, AN ATTEMPT TO INSERT AN SI BRITE TIP SHEATH (6F 11CM STR) INTO THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS UNSUCCESSFUL AND THE DISTAL TIP OF THE SHEATH BECAME FRAYED. A SECOND SI BRITE TIP SHEATH (6F 11CM STR) WAS OPENED AND INSERTION WAS ATTEMPTED AGAIN WITH THE SAME RESULTS. A NON-CORDIS SHEATH WAS OPENED AND WAS ABLE TO BE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A LITTLE CALCIFICATION REPORTED AT THE INSERTION SITE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE CLINICALLY USED. THE DEVICE HAS BEEN DISCARDED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE PACKAGE. THE DEVICES WERE STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPPED PER THE IFU. THERE WAS NO DAMAGE NOTED TO THE DEVICES BEFORE ATTEMPTING INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8312780 ↗