Brite Tip Radianz 687280110Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032081228), received between Aug 23, 2022 and Jul 31, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Material Frayed; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104087 ↗
• MalfunctionMar 3, 2026Material Frayed; Material Split, Cut or Torn

  AS REPORTED, AFTER ONE DILATION OF A NON-CORDIS 6 X 20 CUTTING BALLOON, RESISTANCE WAS FELT WHEN ATTEMPTING TO REMOVE THE CUTTING BALLOON FROM A 110CM BRITE TIP RADIANZ CATHETER SHEATH INTRODUCER (CSI) AND THE CUTTING BALLOON AND BRITE TIP RADIANZ CSI WERE REMOVED TOGETHER. OUTSIDE OF THE PATIENT, THE TIP OF THE BRITE TIP RADIANZ CSI WAS FOUND FRAYED AND PARTIALLY PEELED. A NEW 110CM BREIT TIP RADIANZ CSI WAS USED AS A REPLACEMENT TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT THE COMMON ILIAC ARTERY (CIA) FROM A TRANS-RADIAL ARTERY (TRA) APPROACH. THE NON-CORDIS CUTTING BALLOON WAS USED FOR PRE-DILATION AND WAS FULLY DEFLATED BEFORE REMOVAL. IT WAS REPORTED THAT THERE WAS POOR RE-WRAPPING OF THE BALLOON. THE BRITE TIP RADIANZ CSI WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND NO DIFFICULTY WAS ENCOUNTERED WHEN FLUSHING THE DEVICE PRIOR TO USE. NO DAMAGE WAS OBSERVED ON THE BRITE TIP SHEATH BEFORE USE. THERE WAS NO DIFFICULTY INSERTING THE BRITE TIP CSI INTO THE PATIENT AND NO RESISTANCE OR FRICTION DURING INSERTION OF THE CUTTING BALLOON. THERE WAS NO INDICATION THAT ANY PORTION OF THE BRITE TIP CSI D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498791 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE RADIANCY STUDY, THERE WAS OCCLUSION OF LEFT RADIAL ARTERY (PUNCTURE SITE). IT WAS NOTED THAT JUST THE SHEATH WAS RELATED TO THE OCCLUSION. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE AND CLAUDICATION. THE LESION WAS IN THE LEFT COMMON ILIAC ARTERY. THE LESION WAS NOTED TO HAVE MILD CALCIFICATION WITH 90% STENOSIS. THE LESION WAS MEASURED TO BE 30MM IN LENGTH, 10MM IN DIAMETER, AND 3 MM INNER LUMEN DIAMETER. THE RADIAL ARTERY WAS MEASURED TO BE 3MM IN DIAMETER. THE LEFT DISTAL RADIAL ARTERY WAS USED FOR ACCESS. ULTRASOUND WAS USED DURING ACCESS. A 6F 110CM CORDIS RADIANZ SHEATH WAS INSERTED SUCCESSFULLY. NO VASOSPASM OCCURRED. THERE WAS NO PAINT DURING INSERTION. AN UNKNOWN GUIDEWIRE CROSSED THE TARGET LESION. PRE-DILATION WAS PERFORMED WITH AN 8X4 SABERX RADIANZ BALLOON. INFLATION AND DEFLATION OF THE BALLOON WAS SUCCESSFUL. THE 8X4 BALLOON WAS WITHDRAWN. THE LESION HAD A 50% RESIDUAL STENOSIS AFTER PRE-DILATION. A 10X40 SMART RADIANZ STENT WAS PLACED. A SECOND 9X40 SMART RADIANZ SETNT WAS SUCCESSFULLY PLACED AT THE INTENDED LESION. BOTH THE SYSTEMS WERE WITHDRAWN SUCCESSFULLY AFTER USE. THE LESION WAS NOTED TO HAVE A 10% RESIDUAL STENOSIS AFTER STENT PL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840889 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, ONE DAY AFTER A PROCEDURE IN WHICH A 6F 110CM BRITE TIP RADIANZ CATHETER SHEATH INTRODUCER (CSI) WAS USED, THERE WAS AN OCCLUSION OF THE LEFT RADIAL ARTERY WHICH WAS RELATED TO THE USE OF A 6F 110CM BRITE TIP RADIANZ CSI. THE OCCLUSION REPORTEDLY RESOLVED ON ITS OWN FOUR WEEKS AFTER OBSERVATION. NO INTERVENTIONS WERE PERFORMED TO TREAT THE OCCLUSION. THIS WAS DURING A RADIANCY STUDY PROCEDURE IN WHICH VASCULAR ACCESS WAS OBTAINED IN THE LEFT RADIAL ARTERY UNDER DUPLEX ULTRASOUND GUIDANCE. 5 ML¿S OF HEPARIN WERE GIVEN AND AN UNKNOWN 4F 100CM CSI WAS INSERTED. AN UNKNOWN GUIDEWIRE WAS THEN INSERTED SUCCESSFULLY ACROSS THE TARGET RIGHT COMMON ILIAC ARTERY LESION. THE RIGHT ILIAC ARTERY LESION WAS 30MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 8MM. THE LESION WAS A 100% STENOSED DE NOVO LESION WITH A MINIMUM LUMEN DIAMETER OF 3MM. AFTER INSERTION OF THE UNKNOWN GUIDEWIRE, THE UNKNOWN 4F 100CM CSI WAS EXCHANGED FOR A 6F 110 CM BRITE TIP RADIANZ CSI WHICH WAS SUCCESSFULLY INSERTED INTO THE PERIPHERAL VASCULATURE THROUGH THE RADIAL ARTERY. NEXT, PRE-DILATION OF THE LESION WAS PERFORMED WITH AN 8MM X 3CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CA

  Patient problems: Obstruction/Occlusion

  MAUDE report 17740847 ↗
• MalfunctionJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE RADIANCY STUDY, THE PATIENT EXPERIENCED STENOSIS OF THE RADIAL ARTERY APPROXIMATELY ONE MONTH AFTER INITIAL PROCEDURE. THIS WAS NOTED TO BE RELATED TO THE BRITE TIP SHEATH. THE STENOSIS WAS THE RESULT OF THE TRAUMA THAT WAS CAUSED BY THE PASSING DEVICE. APPROXIMATELY 2 WEEKS POST PROCEDURE, THE PATIENT EXPERIENCED WORSENED CARPAL TUNNEL SYNDROME. THIS WAS NOTED TO BE POSSIBLY RELATED TO THE PROCEDURE OR ANY OF THE DEVICES USED. THE CTS IS A PRE-EXISTING CONDITION WITH ONSET APPROX. A YEAR PRIOR TO THE PATIENT¿S INDEX PROCEDURE DATE. APPROXIMATELY 6 WEEKS AFTER INITIAL PROCEDURE, NEUROLYSIS OF THE NERVE WAS PERFORMED. THE RADIAL ARTERY STENOSIS WAS MILD AND WAS NOTED TO BE DEFINITELY RELATED TO THE PROCEDURE. THERE HAS BEEN NO TREATMENT TO THE STENOSIS SITE. THE LEFT DISTAL RADIAL ARTERY WAS USED FOR ACCESS VIA ULTRASOUND. THE PATIENT WAS NOTED TO HAVE PERIPHERAL ARTERY DISEASE AND A RUTHERFORD/BECKER CLASSIFICATION OF STAGE 3. THE PATIENT HAS A HISTORY OF HYPERTENSION AND A HISTORY OF SMOKING. THE LESION WAS IN THE RIGHT COMMON FEMORAL ARTERY (CFA). THE LESION WAS NOTED TO HAVE MILD CALCIFICATION WITH A 60% STENOSIS. THE LESION WAS 20MM LONG AND THE TOTAL VESSEL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17208998 ↗
• MalfunctionJun 12, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE 110CM BRITE TIP RADIANZ WAS BEING DELIVERED TO A LESION BUT THE DISTAL END GOT FRAYED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107811 ↗
• MalfunctionApr 10, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE HEMOSTASIS VALVE AT THE PROXIMAL SIDE OF A 110 CM BRITE TIP RADIANZ GUIDING SHEATH DID NOT CLOSE. THERE WAS A POSSIBILITY THAT THE TIP GOT FRAYED. THERE WAS NO REPORTED PATIENT INJURY. IT WAS DIFFICULT FOR THE DEVICE TO BE INSERTED FROM THE SKIN THEREFORE, A CUT DOWN WAS DONE, AND THE DEVICE WAS INSERTED. AFTER THAT, THE PHYSICIAN NOTICED THAT THE HEMOSTASIS VALVE AT THE PROXIMAL SIDE DID NOT CLOSE THEREFORE, THERE WAS A ¿STEP¿ BETWEEN THE TIP AND THE DILATOR AND THERE WAS A POSSIBILITY THAT THE TIP GOT FRAYED. THE DEVICE WAS FLUSHED PRIOR TO USE. THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. THERE WERE DIFFICULTIES ENCOUNTERED DURING THE INSERTION PROCESS. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING THE WITHDRAWAL PROCESS. THERE WERE NO DAMAGES NOTED TO THE VALVE PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THERE WERE NO DIFFICULTIES ENCOUNTERED WHILE INSERTING OR WITHDRAWING ANY CONCOMITANT DEVICES. THE DEVICE WAS USED WITHOUT PROBLEM AFTER INSERTION AND AN UNKNOWN SMART STENT (RADIANZ) WAS IMPLANTED AT BOTH OF THE ILIAC ARTERIES AND THE PROCEDURE COMPLETED. THE LESIONS WERE BOTH AT THE ILIAC ARTERIES WHICH HAD STENOSIS. INSERTION SITE VESSEL HAD MOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706772 ↗
• MalfunctionAug 23, 2022Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED, THE DISTAL 30CM PORTION OF A 110CM BRITE TIP RADIANZ CATHETER SHEATH INTRODUCER APPEARED TO BE "STRETCH/RIBBON." IT IS SUSPECTED THAT IT RIBBONED BECAUSE THE USER REMOVED THE SHEATH WITHOUT HAVING A WIRE OR DILATOR IN. FOLLOWING COMPLETION OF THE INTERVENTION, THE PHYSICIAN WAS ABLE TO REMOVE THE BRITE TIP RADIANZ OVER AN UNKNOWN GUIDEWIRE. THE RIGHT FEMORAL ARTERY WAS CLOSED WITH MYNX GRIP. THERE WAS NO REPORTED PATIENT INJURY. NO DAMAGE TO THE VESSEL OR PATIENT. NO COMPLICATIONS FOLLOWING THE PROCEDURE. THE BRITE TIP WAS USED FOR A LEFT LOWER EXTREMITY ANGIOGRAM, THROUGH THE RIGHT COMMON FEMORAL ARTERY. THROUGHOUT CASE THE PHYSICIAN USED AN UNKNOWN DRUG COATED BALLOON (DCB) AND SHOCKWAVE. AN IMAGE REVIEW WAS COMPLETED FOR THREE IMAGES RECEIVED, AND THEY SHOW WHAT APPEARS TO BE STRETCHING OF A CATHETER. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276227 ↗