Skip to content

Guardus 00711148Recalls & reported problems

US Endoscopy · The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816765011225), received between Sep 6, 2018 and Sep 6, 2018 — classified as 1 malfunction.

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 Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionSep 6, 2018Detachment of Device or Device Component

    THE DISTRIBUTOR IN (B)(4) REPORTED THE TIP DETACHED FROM A GUARDUS OVERTUBE DURING PROCEDURAL USE. THE DETACHED PORTION WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT OR USER HARM AS A RESULT OF THE COMPONENT DETACHMENT NOR RETRIEVAL.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7852897 ↗

Other endoscopic access overtube, gastroenterology-urology devices

All endoscopic access overtube, gastroenterology-urology devices →

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