ClearPetra 90111236Recalls & reported problems
Well Lead Medical Co.,Ltd · ClearPetra Ureteral Access Sheath, 12Fr×36cm · 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 06944932747920), received between Sep 24, 2026 and Sep 24, 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
- Unspecified Kidney or Urinary Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Insufficient Device Problem Information
It was reported that the doctor split the ureter. He was near the UPJ and while he was maneuvering the ClearPetra sheath, the surgeon split the ureter. The case had to be stopped. A stent was then placed in the patient and the doctor said he would let it heal and come back in a month. The device was disposed.
Patient problems: Unspecified Kidney or Urinary Problem
MAUDE report 50884594 ↗
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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.