Fusion Quattro G31921Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002319219), received between Dec 7, 2017 and Nov 19, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Deflation Problem; Deflation Problem

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON FOR STONE REMOVAL. IT WAS REPORTED THAT THE BALLOON WAS CONFIRMED TO BE NORMAL AND FUNCTIONAL BEFORE USE. THE BALLOON WAS INFLATED INSIDE THE BILIARY DUCT. WHILE ATTEMPTING TO DEFLATE THE BALLOON NEAR THE AMPULLA DURING STONE REMOVAL, THE NURSE TRIED TO MANIPULATE THE SYRINGE THAT WAS INCLUDED IN THE PRODUCT PACKAGING, BUT IT DID NOT MOVE, AND THE BALLOON DID NOT DEFLATE. AS SUCH, THE BALLOON WAS FORCEFULLY BURST AND THEN REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23596903 ↗
• MalfunctionDec 6, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. A STONE WAS TAKEN OUT WITH THE FIRST USE OF THE DEVICE, BUT WHEN THEY ATTEMPTED TO TAKE OUT THE REST OF THE STONES, THEY FOUND OUT THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER COOK FUSION QUATTRO EXTRACTION BALLOON. THIS EVENT WAS NOT REPORTABLE AT THAT TIME. ON 12-NOV-2019, THE DEVICE RETURNED. THE SECTIONS OF THE BALLOON DO NOT MATCH UP [PIECES OF THE BALLOON MATERIAL ARE MISSING]. IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE LOCATION OF THE MISSING PORTIONS IS UNKNOWN. 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: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9432763 ↗
• MalfunctionDec 12, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. ALL THE INFORMATION I HAVE IS ON A NOTE THAT IS STUCK TO THE PACKAGE WHICH SAYS, "SPLIT AT END BY ANOTHER MANUFACTURER'S WIRE GUIDE." THE CUSTOMER DOES NOT RECALL HOW OR WHEN THIS OCCURRED. I DO NOT KNOW WHEN THIS OCCURRED. THE DEVICE WAS EVALUATED ON 11/17/2017 AND IT WAS OBSERVED THAT THE INTRADUCTAL EXCHANGE (IDE) PORT WAS DAMAGED AND PROTRUDING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7108435 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON (FS-QEB-XL-A). PER THE INITIAL REPORTER: ¿DR. (B)(6) USED [FOR THE] FIRST TIME A FS-QEB-XL-A EXTRACTION BALLOON; BEFORE, HE HAD ALWAYS USED ANOTHER MANUFACTURER'S EXTRACTION BALLOONS. FIRST, A SPHINCTEROTOMY WAS PERFORMED AND ANOTHER MANUFACTURER'S WIRE GUIDE WAS INTRODUCED IN BILE DUCT OVER WHICH THE FS-QEB-XL-A WAS ADVANCED INTO THE DUCT. ACCORDING TO THE NURSE, THE BALLOON WAS INFLATED UP TO 15 MM. WHEN THE BALLOON WAS RETRACTED, IT SUDDENLY BURST. THE PHYSICIAN STATES THAT THIS CAUSED A PERFORATION OF THE PAPILLARY ROOF (WITH VISIBILITY OF THE INTRAMURAL PART OF THE BILE DUCT). A CLIP WAS PLACED TO CLOSE THE PERFORATION, AND A COOK 10 FRENCH, 7 CM COTTON LEUNG STENT WAS PLACED INTO THE BILE DUCT. A LITTLE OOZING BLEEDING WAS VISIBLE, BUT WITHOUT NEED OF FURTHER INTERVENTION. LATER, THE BLEEDING GOT MORE INTENSIVE, SO THE PATIENT RECEIVED TWO BLOOD TRANSFUSIONS, PLUS ANTIBIOTICS AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. THE BALLOON WAS DISCHARGED [DISCARDED] DURING THE STRESSFUL SITUATION AND IS NOT AVAILABLE FOR FURTHER EXAMINATIONS [INVESTIGATION].¿ T

  Patient problems: Perforation

  MAUDE report 7097249 ↗