ClearPetra 90111150Recalls & reported problems
Well Lead Medical Co.,Ltd · ClearPetra Ureteral Access Sheath 11Fr x 50cm · Class 2
Data updated Oct 16, 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 06936881196270), received between Apr 17, 2025 and Apr 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- Perforation1
- Rupture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT ONE OF THE SHEATH DID CAUSE INJURY TO THE PATIENTS URETER AND ENDED UP PERFORATING IT AND IT COULD BE THAT THE SURGEONS TRIED TO PUSH TOO HARD INTO THE KIDNEY AND IT COULD HAVE BEEN THE REASON FOR THE TEAR . A FURTHER EVALUATION CANNOT BE CONDUCTED AS KARL STORZ IS NOT THE LEGAL MANUFACTURER OF THE DEVICE. THE KARL STORZ TEAM DID NOTIFY THE THIRD PARTY DISTRIBUTOR (B)(4) OF THE EVENT REPORT REQUIRED ON APRIL 1,2025.
Patient problems: Perforation; Rupture
MAUDE report 21861810 ↗
Other Endoscopic Access Overtube, Gastroenterology-Urology devices
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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