Fusion Quattro G48226Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002482265), received between Jul 20, 2017 and Jun 1, 2022 — classified as 3 malfunctions.

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

• MalfunctionJun 1, 2022Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED THAT THE PHYSICIAN WANTED THE BALLOON TURN DOWN TO 8.5MM, BUT THE NURSE FOUND THAT THE BALLOON COULDN'T TURN DOWN DEFLATE. THE PHYSICIAN USED FORCE TO PULLED IT OUT OF THE PAPILLA. 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 14565075 ↗
• MalfunctionMar 16, 2018Material Fragmentation; Material Fragmentation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK FUSION QUATTRO EXTRACTION BALLOON. OUT OF THE PACKAGE, THIS BALLOON WOULD NOT INFLATE OR HOLD AIR. IT DID NOT MAKE PATIENT CONTACT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 02/20/2018 AND IT WAS DETERMINED THAT PART OF THE BALLOON MATERIAL IS MISSING.

  Patient problems: No Patient Involvement

  MAUDE report 7346288 ↗
• MalfunctionJul 20, 2017Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. AS REPORTED TO CUSTOMER RELATIONS, "WHILE IN THE COMMON BILE DUCT DOING A STONE EXTRACTION, THE BALLOON WAS INFLATED TO SWEEP THE DUCT AND THE BALLOON WOULD NOT DEFLATE. EVENTUALLY THEY WERE ABLE TO GET THE BALLOON OUT OF THE DUCT. THE BALLOON WAS REMOVED FROM THE PATIENT AND A NEW FS-QEB-B WAS OPENED AND USED TO COMPLETE THE PROCEDURE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6727454 ↗