Infinity 00711653 (UDI 00724995184049)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995184049), received between Jun 5, 2020 and Jul 5, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE FLUOROSCOPIC TIP TO THEIR INFINITY ERCP SAMPLING DEVICE BROKE OFF INSIDE THE PATIENT'S PANCREATIC DUCT. A PROCEDURE DELAY WAS REPORTED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19679760 ↗
• MalfunctionJun 5, 2020Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHILE SAMPLING A STRICTURE IN THE BILIARY TRACT THE BRUSH OF AN INFINITY SAMPLING DEVICE BECAME DETACHED. THE BRUSH COMPONENT WAS REMOVED FROM THE BILIARY TRACT WITH A FORCEPS, THEN RETRIEVED WITH A SNARE AND HOOD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE TISSUE SAMPLE WAS OBTAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10125303 ↗