VISTA BRITE TIP 67005600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032020210), received between Aug 4, 2022 and May 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

1 other recall cover devices cleared under the same FDA submission (K963962); 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. 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.

• MalfunctionMay 5, 2023Crack; Crack

  AS REPORTED, A 6F .070 XB 4 100CM VISTA BRITE TIP GUIDING CATHETER WAS FOUND FRACTURED IN THE MEDIAL SEGMENT DURING PREP. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER 6F VISTA BRITE TIP XB4 CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. NEITHER THE PRODUCT NOR ANY OR ANY OF THE OTHER DEVICES USED WITH IT HAD BEEN RE-STERILIZED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE RETURN STATUS OF THE DEVICE; HOWEVER, THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16879688 ↗
• MalfunctionAug 4, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED, THE PHYSICIAN HAD DIFFICULTY GETTING ACCESS WITH A 6F RAIN SHEATH AND DIFFICULTY INSERTING THE SHEATH. THE RAIN SHEATH WAS REMOVED; A SKIN NICK WAS MADE, AND THE RAIN SHEATH WAS REINSERTED STILL WITH A LITTLE DIFFICULTY. DURING HEART CATHETERIZATION IT WAS DIFFICULT TO MANIPULATE THE DIAGNOSTIC CATHETERS. THE PHYSICIAN CHANGED TO A 6F VISTA BRITE TIP (XB4) GUIDING CATHETER WHICH WAS DIFFICULT TO MANIPULATE AND TORQUE; IT WAS DIFFICULT TO REMOVE THE GUIDING CATHETER, AND THE PHYSICIAN REMOVED THE SHEATH, WIRE, AND THE GUIDE CATHETER. UPON REMOVAL IT WAS NOTICED THAT THE 6F RAIN SHEATH HAD ACCORDIONED. THE PROCEDURE WAS COMPLETED USING A NON-CORDIS SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB. THE PRODUCT WAS STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE DEVICE PREPPED NORMALLY. DURING THE SAMPLE PREP STEP (PER IFU) THE CATHETER SHEATH INTRODUCER (CSI) WAS SOAKED FOR 5-10 MINUTES AND IT WAS ALSO WIPED DOWN WITH A WET GAUZE. THE CSI DID NOT REMAIN EXPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15168322 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963962. One submission often covers many models, so check the product and lot details in each record.

• 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