Proxis Ureteral Access Sheath 231125Recalls & reported problems
C. R. Bard, Inc. · Proxis Ureteral Access Sheath · Class 2
All models of Proxis Ureteral Access Sheath (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741212741), received between Jul 20, 2023 and Mar 7, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Fragmentation1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DILATOR LOCK BROKE AS A SURGEON WAS GRASPING IT AND TRIED TO SEPARATE IT FROM THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547850 ↗InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED INFLAMMATION, URETERAL PERFORATION PRIOR TO THE DEVICE PLACEMENT AND INFLAMMATION, HEMORRHAGE COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND TECHNICAL ERROR WAS NEEDED FOR HEMORRHAGE IN RELATION TO 231125 - PROXIS¿ URETERAL ACCESS SHEATH - OUTER DILATOR 11 FR/SHEATH DIAMETER 13FR, LENGTH 25CM. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation
MAUDE report 17358097 ↗
Other endoscopic access overtube, gastroenterology-urology devices
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- 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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