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Infinity 00711653 (UDI 00816765012758)Recalls & reported problems

US Endoscopy · The disposable Infinity ERCP sampling device is used to retrieve cytological cell samples in the gastrointestinal tract. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816765012758), received between Apr 10, 2019 and Apr 10, 2019 — classified as 1 injury.

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

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 10, 2019Detachment of Device or Device Component

    REFERENCE USER FACILITY MEDWATCH REPORT #5085400. THE USER FACILITY REPORTED THAT FOLLOWING A SAMPLING PROCEDURE, THE FLUOROSCOPIC MARKER FROM THE INFINITY SAMPLING DEVICE WAS DETECTED IN THE BILIARY DUCT. INTERVENTION WAS REQUIRED TO RETRIEVE THE MARKER.

    Patient problems: No Code Available

    MAUDE report 8501918 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.