Infinity 00711652 (UDI 00724995184032)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00724995184032), received between Sep 25, 2020 and Oct 18, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2023Break; Break

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE SHEATH WIRE TO THEIR INFINITY ERCP SAMPLING DEVICE BROKE WHILE BRUSHING THE BILE DUCT CAUSING A PROCEDURE DELAY. A REPLACEMENT BRUSH WAS UTILIZED IN ORDER TO COMPLETE THE PROCEDURE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17960629 ↗
• MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) THAT DURING A PATIENT PROCEDURE, THE END OF THE BRUSH DETACHED FROM THEIR INFINITY ERCP SAMPLING DEVICE. THE BRUSH WAS FULLY RETAINED AND RETRIEVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16613564 ↗
• MalfunctionNov 25, 2020Material Separation

  THE DISTRIBUTOR REPORTED THAT A METAL PORTION OF THE SAMPLING DEVICE WAS LEFT BEHIND FOLLOWING A SAMPLING PROCEDURE IN THE BILE DUCT, AS DETECTED VIA CHOLANGIOGRAM. THE USER FACILITY PLACED A COVERED STENT AT THE SITE OF THE REPORTED EVENT TO PREVENT INJURY TO THE BILE DUCT.

  Patient problems: Insufficient Information

  MAUDE report 10899970 ↗
• MalfunctionSep 25, 2020Detachment of Device or Device Component

  THE DISTRIBUTOR REPORTED THAT THE BRUSH HEAD COMPONENT OF AN INFINITY ERCP SAMPLING DEVICE DETACHED DURING A PATIENT PROCEDURE FOR SAMPLING A TUMOR IN THE BILE DUCT. THE BRUSH HEAD WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED. NO HARM TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10588753 ↗