BRITE TIP 401723MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032000314), received between Jul 9, 2019 and Jan 13, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, NEAR THE OPAQUE MARKER OF 7F 23CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) WAS NOTICED TO BE FRAYED. THE BRITE TIP CSI WAS ATTEMPTED TO BE INSERTED FROM THE RIGHT COMMON FEMORAL ARTERY BUT WAS UNABLE TO. THE 7F BRITE TIP CSI WAS REPLACED WITH ANOTHER 7F 23CM BRITE TIP CSI AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT COMMON ILIAC ARTERY. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163677 ↗
• MalfunctionOct 7, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE DISTAL END OF A 7F 23CM BRITE TIP STRAIGHT CATHETER SHEATH INTRODUCER WAS ATTEMPTED TO USED BUT WAS FRAYED. THE DEVICE WAS REPLACED WITH ANOTHER BRITE TIP CSI AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU) . THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567661 ↗
• MalfunctionOct 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE VALVE OF THE TWO (2) 7F 23CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) LEAKED A LOT AND THE CAP COMING OFF THE SHEATH JUST BY TAKING OUT THE UNKNOWN WIRE FROM THE SHEATH. THE PHYSICIAN WAS ABLE TO TAKE OUT THE LEAKING SHEATH AND REPLACE IT WITH A NEW UNKNOWN SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR WAS TRAINED TO THE BRITE TIP SHEATH. THE DEVICES WERE OPENED IN STERILE FILED. ONLY ONE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712676 ↗
• MalfunctionOct 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE VALVE OF THE TWO (2) 7F 23CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) LEAKED A LOT AND THE CAP COMING OFF THE SHEATH JUST BY TAKING OUT THE UNKNOWN WIRE FROM THE SHEATH. THE PHYSICIAN WAS ABLE TO TAKE OUT THE LEAKING SHEATH AND REPLACE IT WITH A NEW UNKNOWN SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR WAS TRAINED TO THE BRITE TIP SHEATH. THE DEVICES WERE OPENED IN STERILE FILED. ONLY ONE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712639 ↗
• MalfunctionJul 9, 2019Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A BRITE TIP SHEATH (SI BRITE TIP 7F 23CM STR) WAS INSERTED INTO THE PATIENT. UPON RADIOGRAPHIC EXAMINATION, THE TIP WAS NOTED TO BE SPLIT. THE SHEATH WAS REMOVED WITHOUT INCIDENT AND REPLACED WITH ANOTHER SHEATH TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771733 ↗