BRITE TIP 55608200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032064207), received between Feb 18, 2021 and Feb 18, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K021593); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2021Leak/Splash; Material Puncture/Hole; Separation Failure; Leak/Splash; Material Puncture/Hole; Separation Failure

  DURING USE IN PATIENT, THE 5F INFINITI CATHETER PROPAC WAS LEAKING. DURING FAL ANALYSIS, IT WAS NOTED THAT THE WIRE WAS EXPOSED ON THE BODY OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS STORED PER THE IFU. THE CATHETER WAS INJECTED WITH CONTRAST AS IT WAS ENTERING THE PATIENT. THE DOCTOR NOTICED A SMALL LEAK AT THAT POINT. IT WAS REMOVED WITH NO NEGATIVE OUTCOME. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED. ADDENDUM: PRODUCT ANALYSIS DEMONSTRATES A LEAKAGE WAS NOTED FROM DISTAL TIP AND A PUNCTURE/HOLE IS NOTED, THROUGH THIS DAMAGE THE LIQUID WAS LEAKING. THE RESULTS SHOWED THAT THE OUTER SURFACE OF THE CATHETER UNIT PRESENTED BULGED/PEELED OFF MATERIAL ALONG THE PUNCTURE/HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11344559 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021593. One submission often covers many models, so check the product and lot details in each record.

• Z-1330-2025 · Feb 7, 2025 · Open, Classified
  Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices
• Z-1198-2019 · Feb 7, 2019 · Terminated
  Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into
• Z-0434-05 · Dec 7, 2004 · Terminated
  VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.