BRITE TIPRecalls & reported problems across all models
Cordis US Corp. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 20 models of BRITE TIP by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2017 and Jan 5, 2026 — classified as 12 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (20 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
Reports received per month, all models
Most reported BRITE TIP problems
Device problems
- Detachment of Device or Device Component20
- Material Frayed18
- Material Split, Cut or Torn18
- Difficult to Remove4
- Unraveled Material3
- Crack2
- Device Contamination with Chemical or Other Material2
- Stretched2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient8
- Perforation of Vessels2
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Internal Organ Perforation1
- No Known Impact Or Consequence To Patient1
BRITE TIP models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BRITE TIP 401511MINTRODUCER, CATHETER10 reports
- BRITE TIP 401711MINTRODUCER, CATHETER6 reports
- BRITE TIP 401723MINTRODUCER, CATHETER5 reports
- BRITE TIP 401811MINTRODUCER, CATHETER4 reports
- BRITE TIP 401605MINTRODUCER, CATHETER3 reports
- BRITE TIP 401655MINTRODUCER, CATHETER3 reports
- BRITE TIP 401823MINTRODUCER, CATHETER3 reports
- BRITE TIP 5560540LCATHETER, PERCUTANEOUS3 reports
- BRITE TIP 401645MINTRODUCER, CATHETER2 reports
- BRITE TIP 401690MINTRODUCER, CATHETER2 reports
- BRITE TIP 401745MINTRODUCER, CATHETER2 reports
- BRITE TIP 401023MINTRODUCER, CATHETER1 report
- BRITE TIP 401555MINTRODUCER, CATHETER1 report
- BRITE TIP 401705MINTRODUCER, CATHETER1 report
- BRITE TIP 401805MINTRODUCER, CATHETER1 report
- BRITE TIP 401835MINTRODUCER, CATHETER1 report
- BRITE TIP 401911MINTRODUCER, CATHETER1 report
- BRITE TIP 401935MINTRODUCER, CATHETER1 report
- BRITE TIP 5560020LCATHETER, PERCUTANEOUS1 report
- BRITE TIP 55608200CATHETER, PERCUTANEOUS1 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.
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 ↗MalfunctionJan 5, 2026Material Frayed
AS REPORTED, THE DISTAL END OF A 6F 90CM SI BRITE TIP CATHETER SHEATH INTRODUCER WAS FOUND BROKEN/DAMAGED UPON OPENING. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957453 ↗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 ↗MalfunctionApr 28, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, UPON UNPACKING, THE 6F 45CM BRITE TIP SHEATH INTRODUCER WAS FOUND DEFECTED. PER THE TWO IMAGES PROVIDED, THERE APPEARS TO BE A DARK-COLORED, NON-MOVEABLE PARTICLE ON THE CANNULA. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS NOT USED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21921431 ↗MalfunctionNov 19, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn
AS REPORTED, THE DOCTOR FELT RESISTANCE WHEN THE 6F 55CM BRITE TIP SHEATH INTRODUCER WAS INSERTED. THE SHEATH WAS REMOVED AND THE TIP GOT FRAYED. IT WAS REPLACED WITH A NEW BRITE TIP SHEATH (DIFFERENT LOT#) AND THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE WERE REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20730450 ↗InjurySep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A SINGLE CD-ROM CONTAINING 12 IMAGES WAS SUBMITTED FOR REVIEW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20332913 ↗InjurySep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE TIP OF THE 6F 5.5CM BRITE TIP SHEATH INTRODUCER BROKE; THE RADIOPAQUE TIP SEPARATED FROM THE REST OF THE CATHETER AND EMBEDDED IN THE PATIENT, RESULTING IN TWO PIECES. THERE WAS NO REPORTED PATIENT INJURY. NO ANOMALIES WERE NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND IT WAS INSPECTED AND PREPPED PER THE IFU WITHOUT ANY DIFFICULTY. NO RESISTANCE OR FRICTION WAS EXPERIENCED DURING ANY PART OF THE PROCEDURE, AND NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE. UNUSUAL FORCE WAS NOT NECESSARY DURING THE USE OF THE DEVICE, AND EXCESSIVE TORQUING WAS NOT REQUIRED. THE TIP WAS VISIBLE ON FLUOROSCOPY THROUGHOUT THE PROCEDURE. THE EXAM WAS COMPLETE AT THIS POINT, AND ANOTHER BRITE TIP SHEATH WAS NOT USED. THE CUSTOMER PULLED THE BOX OFF THE SHELF AND DID NOT CONFIRM IF THEY WOULD BE RETURNING THE UNUSED UNITS LEFT IN THE BOX OR IF THEY WANTED A CREDIT OR REORDER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20295408 ↗MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THERE WAS A MALFUNCTION OF THE SHAFT OF THE 8F 11 CM BRITE TIP CATHETER SHEATH INTRODUCER. THE SHEATH HUB WAS SHEARED OFF WHEN EXCHANGING TO THE INITIAL 8F SHEATH STARTED WITH THE CASE WHICH WAS REPORTED AS AN ABLATION PROCEDURE. THE ISSUE WAS NOTICED WHEN REMOVING THE EXCHANGE WIRE DURING USE IN THE PATIENT. THE DAMAGE WAS DESCRIBED AS FRAYED AND SPLIT IN 2 PIECES. ANOTHER UNKNOWN DEVICE 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 DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE OR DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689253 ↗MalfunctionJun 26, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn
AS REPORTED, THE 7F 11 CM BRITE TIP CATHETER SHEATH INTRODUCER WAS SORT OF "DENTED" AND IT WAS NOT POSSIBLE TO INTRODUCE THE SHEATH WHEN CHANGING A 6F UNKNOWN SHEATH TO A 7F SHEATH EVEN THOUGH IT WAS A RATHER YOUNG PATIENT WITHOUT A LOT OF PLAQUE. THE DEVICE COULD NOT BE INTRODUCED INTO THE VESSEL. A NEW 7F BRITE TIP SHEATH WAS USED AND WORKED WELL. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND IT WAS PREPPED WITH NO DIFFICULTY. THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE OR DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. SLIGHTLY MORE THAN USUAL FORCE WAS REQUIRED IN ORDER TO POSITION THE SHEATH. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19616632 ↗InjuryJun 10, 2024Material Frayed; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Frayed; Detachment of Device or Device Component; Material Split, Cut or Torn
AS REPORTED, THE 8F 11CM BRITE TIP SHEATH SNAPPED WHILE INSIDE PATIENT. THE 8F SHEATH RUPTURED INTRAVASCULARLY. THE SHEATH WAS EVENTUALLY RETRIEVED PERCUTANEOUSLY VIA LFV, USING A BALLOON TO PULL IT OUT. ALSO TRIED SNARE BUT WAS NOT AVAILABLE. THE DEVICE WAS STORED IN THE LAB WHILE IN THE SHEATHS CUPBOARD. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THE DEVICE WAS DROPPED ASEPTICALLY IN THE STERILE FIELD. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED WHILE FLUSHING THE DEVICE. THE RIGHT FEMORAL VEIN WAS USED FOR ACCESS. THE ACCESS SITE WAS NOT PRE-DILATED. THERE WAS NO RESISTANCE WHILE ADVANCING THE CATHETER THROUGH THE SHEATH. THE SHEATH WAS NOT TORQUED AGAINST RESISTANCE. EXCESS FORCE WAS NOT USED DURING THE PROCEDURE. THERE WAS NO DIFFICULTY TRACKING THROUGH THE VASCULATURE. ATRIAL FLUTTER ABLATION WAS THE INTENDED PROCEDURE. THE DEVICE WILL BE RETURNED FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19497941 ↗InjuryApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, AN 8F 23 CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN WAS FIGURE 8 SUTURING THE ACCESS SITE TO REMOVE THE SHEATH WHEN THIS OCCURRED. MANUAL REMOVAL WAS ATTEMPTED WITH NO SUCCESS. THE PATIENT WAS THE CONVERTED FROM MONITORED ANESTHESIA CARE TO GENERAL ANESTHESIA FOR VASCULAR SURGERY TO MAKE AN INCISION AND EXTRACT THE SHEATH. THE SHEATH TIP WAS REMOVED SUCCESSFULLY FROM THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS PREVIOUSLY EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19201521 ↗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 ↗
Other Cordis US Corp. products
- MYNXGRIP2 models · 2,276 reports · 2 recalls
- Cordis ExoSeal Vascular Closure Device3 models · 1,279 reports
- MYNX CONTROL2 models · 534 reports
- POWERFLEX56 models · 306 reports
- SABER51 models · 270 reports
- Cordis S.M.A.R.T. Control Vascular Stent System30 models · 99 reports · 2 recalls
- INFINITI20 models · 107 reports
- AVIATOR19 models · 75 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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