Cotton-Leung G22622Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002226227), received between Apr 25, 2017 and Jul 12, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2019Material Deformation; Material Deformation

  NEAR THE TAPERED TIP SIDE HOLE WAS BENT. NO ADVERSE PATIENT EFFECTS. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8783918 ↗
• InjuryJun 7, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THEY WERE ABLE TO CONFIRM THE STENT MIGRATION IMMEDIATELY AFTER PLACEMENT OF THE STENT.SO THEY REMOVED MIGRATION STENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6617194 ↗
• MalfunctionApr 25, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THE STENT MIGRATED AND PULLED OUT TO DUODENUM WHEN THE ENDOSCOPE WAS WITHDRAWN AFTER PLACEMENT OF CLSO PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6518019 ↗