Infinity 00711652 (UDI 00816765011782)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816765011782), received between Dec 19, 2019 and Mar 13, 2020 — classified as 1 injury, 1 malfunction.

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. 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.

• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PERFORATION TO THE COMMON BILE DUCT DURING A SAMPLING PROCEDURE WHICH INCLUDED USE OF THE INFINITY ERCP SAMPLING DEVICE. A COVERED STENT WAS PLACED TO ADDRESS THE PERFORATION AND THE PATIENT IS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: Perforation

  MAUDE report 9831987 ↗
• MalfunctionDec 19, 2019Material Separation

  THE USER FACILITY REPORTED THAT DURING A SAMPLING PROCEDURE FLUOROSCOPIC MARKER FROM THE INFINITY SAMPLING DEVICE DETACHED INSIDE THE PATIENT. THE DETACHED PORTION OF THE DEVICE WAS RETRIEVED WITH A SNARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9492264 ↗