Fusion G31531Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002315310), received between Dec 2, 2016 and Feb 3, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2020Off-Label Use; Off-Label Use

  DURING A SPHINCTEROPLASTY PROCEDURE [ABNORMAL USE], THE PHYSICIAN USED A COOK FUSION BILIARY DILATION BALLOON (FS-BDB-8X3). THE USER DILATED THE TARGET SITE USING FS-BDB-8X3 ONCE SUCCESSFULLY. HE ATTEMPTED THE SECOND DILATION BUT THE PRESSURE TO INFLATE THE BALLOON WOULD NOT INCREASE AND HE FOUND THE BALLOON WAS RUPTURED/DAMAGED. THE USER COMMENTED, "CONTACT WITH A BILE DUCT STONE DURING THE FIRST DILATION COULD BE A CAUSE OF THE DAMAGE OF THE BALLOON." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9662130 ↗
• MalfunctionJun 26, 2017Hole In Material; Off-Label Use; Hole In Material; Off-Label Use

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION BILIARY DILATION BALLOON. THE PATIENT UNDERWENT REMOVAL OF COMMON BILE DUCT STONE. DURING THE PROCEDURE, IT WAS CONFIRMED THAT THERE WAS LEAKAGE OF CONTRAST MEDIA FROM THE BALLOON, AS SAME AS PREVIOUS CASES (IT WAS REPORTED UNDER MDR 1037905-2017-00283, MDR1037905-2017-00100 AND MDR 1037905-2016-00485). THE DEVICE WAS USED IN THE DUODENAL PAPILLA [OUTSIDE OF INTENDED USE]. THIS TIME, THE CONTRAST MEDIA LEAKED INTO PAPILLA AND COMMON BILE DUCT. THE PROCEDURE FINISHED WITHOUT ANY ADDITIONAL PROCEDURES. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6666620 ↗
• MalfunctionMar 10, 2017Hole In Material; Off-Label Use; Use of Device Problem; Hole In Material; Off-Label Use; Use of Device Problem

  DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE [AGAINST INTENDED USE], THE PHYSICIAN USED A COOK FUSION BILIARY DILATION BALLOON. WHILE INFLATION OF THE BALLOON TO DILATE THE PAPILLA, IT WAS NOTICED THAT SMALL BUBBLE OCCURRED A LOT FROM THE PAPILLA SIDE. IT WAS NOTICED THAT THE SPRAY OF CONTRAST MEDIA WAS OBSERVED FROM PROXIMAL SIDE OF THE BALLOON. THE BALLOON WOULD NOT INFLATE. IT WAS REPLACED WITH ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6396846 ↗
• MalfunctionDec 2, 2016Hole In Material; Off-Label Use; Hole In Material; Off-Label Use

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK FUSION BILIARY DILATION BALLOON. AFTER PERFORMING EST [SPHINCTEROTOMY] USING AN OLYMPUS' SPHINCTEROTOME, THE USER DILATED THE PAPILLA USING A COOK FUSION BILIARY DILATION BALLOON. THE BALLOON WAS INFLATED, BUT THE INFLATION PRESSURE WAS NOT STABLE, SO THE USER HAD TO KEEP APPLYING PRESSURE TO KEEP THE BALLOON INFLATED. DILATATION OF THE PAPILLA WAS COMPLETED WITH THIS DEVICE, BUT THE USER FOUND THAT THERE WAS A PINHOLE IN THE BALLOON AFTER HE REMOVED IT FROM THE PATIENT. THE USER COMMENTED IT SEEMS UNLIKELY THAT IT'S DUE TO THE ELEVATOR OF THE ENDOSCOPE SINCE IT [THE FAILURE] WAS A PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6141912 ↗