Cotton-Leung G21474Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002214743), received between Mar 30, 2016 and Feb 7, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2020Difficult to Advance; Difficult to Advance

  WHEN THEY DO THE ERCP STONE CASE, ACROBAT2 WAS USED. TO OBTAIN OCCLUSION IMAGE OF BILE AND HEPATIC DUCT, THE NURSE INJECTED CONTRAST. AND THEY EXCHANGED BALLOON FOR INSERT STENT(CLSO-10-9) TO DRAIN. HOWEVER , THE WIRE COULDN'T MOVE AT ALL . SO THE NURSE WAS A BIT UPSET AND REMOVED THE WIRE AND BALLOON SIMULTANEOUSLY. AND RE-CANNULATE VIA BALLLOON AND ACROBAT2 AND SUCCEED. AFTER WIRE LEFT, STENT FOLLOWED THE WIRE TO INSERT THE DUCT. BUT THE STENT COULDN'T MOVE FORWARD BECAUSE OF THE RESISTANCE OF WIRE COATING. SO THEY REMOVED BOTH(STENT AND WIRE)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9680450 ↗
• MalfunctionMar 30, 2016Break; Fracture; Break; Fracture

  WHEN THE SURGEON GRABBED COMMON BILE DUCT (CBD) STENT WITH ENDO SNARE TO REMOVE THE STENT, THE STENT TORE. SNARE WAS REPLACED AND THE STENT WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5534139 ↗