ViperCath XC 035-XC-200-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10852528005695), received between May 19, 2023 and May 19, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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 18, 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.

• InjuryMay 19, 2023Material Separation; Material Separation

  A VIPERCATH XC PERIPHERAL EXCHANGE CATHETER FRACTURED IN A SHEATH AND BECAME STUCK IN THE POPLITEAL ARTERY AT COMPLETE TOTAL OCCLUSION. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE WITH A NON-CSI DEVICE TO RETRIEVE THE CATHETER. THE FRACTURED COMPONENT WAS STUCK IN THE VESSEL. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR AN ENDARTERECTOMY TO REMOVE THE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 16961346 ↗