BRITE TIP 401623MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032000246), received between Jun 3, 2022 and Feb 26, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗