Fusion G31538Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002315389), received between Jul 10, 2018 and Mar 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 24, 2026Deflation Problem

  IN PREPARATION FOR A BILE DUCT STONE REMOVAL PROCEDURE, THE USER SELECTED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED THAT DURING PREPARATION, THE BALLOON WAS OBSERVED TO BE UNABLE TO DEFLATE, AND THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING A NEW COOK FS-8.5-12-15-B DEVICE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679473 ↗
• MalfunctionJul 10, 2018Material Fragmentation; Material Fragmentation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. THE DEVICE WAS USED IN THE BILE DUCT FOR ENDOSCOPIC BILE DUCT STONE REMOVAL, BUT THE BALLOON RUPTURED DURING USE. THE PATIENT HAD A FAVORABLE OUTCOME DESPITE THE EVENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 07-JUNE-2018: THE DEVICE WAS USED IN THE BILE DUCT FOR ENDOSCOPIC REMOVAL OF MULTIPLE BILE DUCT STONES. HOWEVER, BECAUSE THE BALLOON RUPTURED DURING THE SECOND ATTEMPT OF STONE REMOVAL, ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THE PATIENT HAD A FAVORABLE OUTCOME DESPITE THE EVENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 15-JUNE-2018 AND OUR EVALUATION OF THE RETURNED DEVICE DETERMINED PART OF THE BALLOON MATERIAL IS MISSING AND WAS NOT INCLUDED IN THE RETURN OF THE DEVICE. THIS INFORMATION WAS COMMUNICATED TO THE USER FACILITY AND THE LOCATION OF THE MISSING SECTION IS UNKNOWN. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE LOCATION OF THE MISSIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7674549 ↗