Roth Net 00711050 (UDI 00816765010860)Recalls & reported problems
US Endoscopy · The disposable Roth Net foreign body standard retrieval device is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816765010860), received between Mar 6, 2018 and Apr 3, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment Of 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Difficult to Open or Close1
- Difficult to Remove1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2020Difficult to Open or Close
A USER FACILITY REPORTED THROUGH THE DISTRIBUTOR IN (B)(6) THAT A ROTH NET DEVICE DID NOT FULLY OPEN NOR FULLY CLOSE DURING A PROCEDURE. THE ROTH NET WAS REPLACED WITH A SECOND ROTH NET DEVICE AND THE PROCEDURE WAS COMPLETED. NO HARM TO THE PATIENT OR USER WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9922973 ↗MalfunctionSep 6, 2019Difficult to Remove
THE USER FACILITY REPORTED DIFFICULTY REMOVING A ROTH NET DEVICE WITH CAPTURED MATERIAL DURING A FOOD BOLUS REMOVAL PROCEDURE, RESULTING IN A PROCEDURAL DELAY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED HARM TO THE USER OR PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8971502 ↗MalfunctionMar 6, 2018Detachment Of Device Component
USER FACILITY REPORTED THAT THE NYLON MESH ON A ROTH NET DEVICE DETACHED DURING A FOOD BOLUS RETRIEVAL PROCEDURE. THE DETACHED MESH WAS RETRIEVED WITH A SECOND ROTH NET DEVICE. THE PROCEDURE WAS COMPLETED WITH THE SECOND ROTH NET DEVICE. THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER DUE TO THE DETACHED MESH NOR THE RETRIEVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7315904 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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