Fusion Quattro G31922Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002319226), received between Sep 21, 2017 and Oct 31, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Material Rupture; Material Rupture

  DURING AN UNKNOWN PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON THROUGH THE PAPILLA. IT WAS INITIALLY REPORTED THAT THE BALLOON RUPTURED UPON THE INITIAL INFLATION. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED ON 06OCT2025 AND DURING THE EVALUATION, THE DEVICE WAS DETERMINED TO HAVE MISSING PIECES [SUBJECT OF REPORT]. 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 23442263 ↗
• MalfunctionMay 9, 2025Material Rupture; Material Rupture

  DURING AN ENDOSCOPIC BILIARY STONE REMOVAL, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] THE USER ATTEMPTED TO INFLATE [BALLOON] WITH AIR, BUT THE BALLOON DID NOT INFLATE. THE USE OF THE DEVICE WAS DISCONTINUED, AND A NEW DEVICE (UNKNOWN LOT) WAS USED AND THE PROCEDURE WAS PERFORMED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 15APR2025. IT WAS DETERMINED THAT THERE IS A MISSING SECTION OF THE BALLOON MATERIAL [SUBJECT OF THIS REPORT]. 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 21996516 ↗
• MalfunctionFeb 25, 2025Material Rupture; Material Rupture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED THAT THE BALLOON HAD BURST INSIDE THE BILE DUCT, SO WHEN DOCTOR REMOVED IT FROM THE ENDOSCOPE AND LOOKED AT IT, THERE WAS NO BALLOON MATERIAL AT ALL AT THE TIP. WHEN A REPLACEMENT BALLOON WAS USED TO REMOVE THE STONES, NO FRAGMENTS OF THE RUPTURED BALLOON MATERIAL FROM THE DEFECTIVE PRODUCT WERE FOUND, SO IT IS POSSIBLE THAT SOME MAY REMAIN IN THE BILE DUCT. HOWEVER, BECAUSE A SPHINCTEROTOMY (EST) HAD BEEN PERFORMED AND A WIDE OPENING HAD BEEN SECURED, THE DOCTOR BELIEVES THAT ANY FRAGMENTS OF THE RUPTURED BALLOON MATERIAL WILL FLOW OUT AND DOES NOT CONSIDER THIS A PROBLEM. AS FRAGMENTS OF THE RUPTURED BALLOON MATERIAL WOULD NOT SHOW UP ON A CT SCAN, NO SCANS HAVE BEEN TAKEN. THE DETACHED BALLOON MATERIAL REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. 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

  MAUDE report 21460685 ↗
• MalfunctionApr 2, 2018Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON (FS-QEB-XL-B). A FS-QEB-XL-B WAS USED FOR ENDOSCOPIC BILE DUCT STONE REMOVAL. THE BALLOON DID INFLATE. HOWEVER, IT WOULD NOT DEFLATE. ANOTHER DEVICE OF THE SAME REFERENCE PART NUMBER (RPN) WAS USED INSTEAD. THE FOLLOWING ADDITIONAL WAS RECEIVED ON 03/14/2018: SINCE THE BALLOON WOULD NOT DEFLATE, THE BALLOON WAS COMPELLED [REQUIRED] TO BE DAMAGED BY PULLING THE BALLOON TOWARDS THE ELEVATOR OF THE ENDOSCOPE [IN ORDER TO DEFLATE FOR REMOVAL].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7390310 ↗
• MalfunctionSep 21, 2017Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. AFTER EST [ENDOSCOPIC SPHINCTEROTOMY] WITH A DUODENOSCOPE, THE BALLOON WAS USED IN THE BILE DUCT FOR STONE EXTRACTION. THE BALLOON WAS INFLATED WITH A SYRINGE INCLUDED IN THE DEVICE PACKAGING AND SWEEP [SWEPT] STONE(S) FROM THE BILE DUCT TO THE DUODENUM. AFTER THAT, THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON WITH APPLYING NEGATIVE PRESSURE THROUGH THE SYRINGE, BUT THE BALLOON DID NOT DEFLATE. EVENTUALLY, HE COULD DEFLATE THE BALLOON BY DETACHING THE SYRINGE FROM THE INFLATION PORT AND THE DEVICE WAS REPLACED WITH ANOTHER BALLOON DEVICE. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6882211 ↗