ClearPetra 90111246Recalls & reported problems
Well Lead Medical Co.,Ltd · ClearPetra Ureteral Access Sheath, 12Fr×46cm · Class 2
- 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 06944932748026), received between Jun 15, 2026 and Jun 15, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Rupture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2026Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED: "THE DR. PLACED THE GUIDE WIRE AND CLEAR PETRA SHEAT TO PLACE INSIDE THE PATIENT AS THERE WAS A NARROWING IN THE URETHRA CAUSING A TEAR. HAD TO STOP THE PROCEDURE, ABORT REMOVING THE KIDNEY STONES."
Patient problems: Rupture
MAUDE report 25505497 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.