CORDIS 67000000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032019856), received between May 2, 2019 and Jul 14, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2021Material Deformation

  PATIENT WITH HISTORY OF CORONARY ARTERY DISEASE, TRANSCATHETER AORTIC VALVE REPLACEMENT IN 2015 AND RECENT CHEST PAIN AND ATRIAL FIBRILLATION WAS ADMITTED FOR A HEART CATHETERIZATION WITH PERCUTANEOUS INTERVENTION. THE CORDIS JUDKINS LEFT 3 6F GUIDING CATHETER HAD A KINK IN IT, VISIBLE INSIDE THE PACKAGING. THE CORDIS JUDKINS LEFT 3 6F GUIDING CATHETER WAS REMOVED FROM CARDBOARD AND KINK REMAINED. DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: Atrial Fibrillation; Chest Pain

  MAUDE report 12165893 ↗
• InjuryMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, FEMORAL APPROACH WAS TAKEN USING A VISTA BRITE GUIDING CATHETER 6F .070 JL3 100CM, AND THE PROVIDER NOTED DIFFICULTY TO ENGAGE AND AFTER SOME MANIPULATION OF THE GUIDE CATHETER, IT DEVELOPED A KINK. ATTEMPTS WERE MADE TO UNDO THE KINK BY TURNING IN THE OPPOSITE DIRECTION OF THE TORQUE; HOWEVER, THE GUIDE CATHETER BROKE. THE PATIENT WAS SENT TO SURGERY AND THE CATHETER WAS REMOVED SUCCESSFULLY. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8574654 ↗

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.