Guardus 00711147Recalls & 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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00724995183622), received between Jun 19, 2020 and Jun 19, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
Patient problems
- Laceration(s) of Esophagus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2020Difficult to Remove; Improper or Incorrect Procedure or Method
THE USER FACILITY REPORTED THE INNER TUBE COULD NOT BE REMOVED FROM THE OVERTUBE AFTER PLACEMENT IN THE ESOPHAGUS DURING A FOOD BOLUS PROCEDURE ON A PATIENT WITH A TORTUOUS UPPER ESOPHAGUS. CONTRARY TO THE INSTRUCTIONS FOR USE, THE PROCEDURE WAS COMPLETED WITHOUT REMOVAL OF THE INNER TUBE. FOLLOWING THE PROCEDURE, THE PATIENT WAS TREATED FOR AN ESOPHAGEAL TEAR; HOWEVER, IT IS NOT CLEAR HOW USE OF THE OVERTUBE WITH THE INNER TUBE IN PLACE CONTRIBUTED TO THE REPORTED INJURY.
Patient problems: Laceration(s) of Esophagus
MAUDE report 10176382 ↗
Other endoscopic access overtube, gastroenterology-urology devices
- EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE OLYMPUS SIF TYPE Q180Olympus Medical Systems Corp. · endoscopic access overtube, gastroenterology-urology1 recall42 reports
- Trokamed WA2PS20STROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall2 deaths2 reports
- Trokamed WA2PS20LTROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall2 deaths2 reports
- Trokamed WA2PS18LTROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall0 reports
- Trokamed WA2PS18STROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall0 reports
- Navigator HD M0062502220Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology1 death31 reports
- Navigator HD M0062502230Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology29 reports
- Proxis™ Ureteral Access Sheath 231045C. R. Bard, Inc. · endoscopic access overtube, gastroenterology-urology22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page