BRITE TIPRecalls & reported problems across all models

We found 5 models of BRITE TIP by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between May 16, 2017 and Jul 7, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BRITE TIP problems

BRITE TIP models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BRITE TIP 401611M

  INTRODUCER, CATHETER
  13 reports
• BRITE TIP 401011M

  INTRODUCER, CATHETER
  2 reports
• BRITE TIP 401623M

  INTRODUCER, CATHETER
  2 reports
• BRITE TIP 401855M

  INTRODUCER, CATHETER
  2 reports
• BRITE TIP 401735M

  INTRODUCER, CATHETER
  1 report

Recent BRITE TIP adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionFeb 26, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE DISTAL END OF THE SHEATH SPLIT AND WAS SPLIT OUT OF THE BOX AFTER OPENING A 6F 23 CM BRITE TIP SHEATH INTRODUCER WHICH WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN STERILE FIELD. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, NOT PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468585 ↗
• 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 ↗
• MalfunctionDec 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, IT LOOKS LIKE THERE IS SOME SORT OF OINTMENT AT THE TIP INSIDE THE STERILE PACKAGE OF A 7F 35CM BRITE TIP SHEATH INTRODUCER. THE CONDITION WAS NOTED AFTER THE PRODUCT HAD BEEN RECEIVED, AND STORED IN THE LAB, PRIOR TO USING. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO PACKAGING DAMAGE NOTED, NO DAMAGE TO THE SHIPPING BOX, TO THE OUTER PRODUCT BOX OR THE INNER PRODUCT POUCH. THE STERILE POUCH WAS NOT RECEIVED OPEN/COMPROMISED AND IT WAS NOT DAMAGED. THE PRODUCT WAS NOT PURPOSELY OPENED IN ANTICIPATION OF USE, AND HAD NOT BEEN RESHELVED. THE DEVICE IS EXPECTED TO BE RETUNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18363800 ↗
• 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 ↗
• MalfunctionJun 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HEMOSTASIS VALVE OF A BRITE TIP SHEATH INTRODUCER (SI BRITE TIP 6F 23CM STR) CAME OFF DURING AN ENDOVASCULAR THERAPY (EVT) CASE AS A NON-CORDIS BALLOON CATHETER WAS BEING REMOVED. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE ILIAC ARTERY. THERE WAS MILD CALCIFICATION AND MODERATE VESSEL TORTUOSITY THE PERCENTAGE STENOSIS WAS NOT PROVIDED. IT IS UNKNOWN IF THE DEVICE WAS BEING USED FOR A CHRONIC TOTAL OCCLUSION. THE PRODUCT WAS STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING NOR ANY DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT AND NO EXCESS FORCE USED AT ANY TIME. THE SHEATH WAS NOT KINKED OR HAD BEEN TWISTED/TORQUED PRIOR TO THE SEPARATION. THE PATIENT DID NOT REQUIRE HOSPITALIZATION NOR THE HOSPITALIZATION WAS EXTENDED AS A RESULT OF THIS EVENT. THE DEVICE IS EXPECTED TO BE RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595375 ↗
• 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 ↗
• MalfunctionFeb 25, 2021Crack; Crack

  DURING THE OPERATION, THE TIP OF AN 8F 55CM STRAIGHT (STR) BRITE TIP SHEATH INTRODUCER WAS DAMAGED (CRACKED), AND AN UNKNOWN FILTER HAS NOT BEEN RECOVERED. THE SURGEON WITHDREW THE BRITE TIP, AND THE PROCEDURE WAS COMPLETED USING A NEW UNKNOWN LONG SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS MILDLY TORTUOUS. THE DEVICE HANDLED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE PACKAGING. THERE WERE NO DAMAGES TO THE DEVICE PACKAGING. THERE WAS NO EXCESSIVE FORCE USED. THE RESIDUE WAS NOT LEFT IN THE PATIENT¿S BODY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IMAGES ARE AVAILABLE FOR REVIEW. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11379882 ↗
• 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 ↗
• MalfunctionDec 11, 2019Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A 10F 11CM BRITE TIP CATHETER SHEATH INTRODUCER WAS USED WHEN AN UNKNOWN COVER STENT WAS IMPLANTED. HOWEVER, THE DISTAL END OF THE BRITE TIP GOT FRAYED WHEN IT WAS INSERTED. THERE WAS NO INJURY TO THE PATIENT. THE DEVICE STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE TARGET LESION WAS THE ILIAC ARTERY. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO CALCIFICATION OF THE LESION, NO VESSEL TORTUOSITY BUT WITH 100% STENOSIS. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE AND DURING PREP. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN NEW SHEATH. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS BECAUSE IT WAS DISCARDED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9452290 ↗

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