Forté® AxP Access Sheath B7086Recalls & reported problems
Applied Medical Resources Corporation · Ureteral Stent Placement Set · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00607915113209), received between Mar 30, 2016 and Mar 30, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2016Break; Break
URETERORENOSCOPY- "DISTAL END OF THE SHEATH BROKE OFF AND WAS FOUND IN THE RENAL CALIX. THE PIECE WHICH WAS BROKEN OFF, HAD TO BE RETRIEVED WITH A STONE RETRIEVAL BASKET." DISTALES ENDE DER SCHLEUSE IST ABGEBROCHEN UND LAG IM NIERENKELCH. (CLEAN BREAK). TYPE OF INTERVENTION - "THE PIECE WHICH WAS BROKEN OFF, HAD TO BE RETRIEVED WITH A STONE RETRIEVAL BASKET." PATIENT STATUS - OK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5536721 ↗
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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