Fusion QuattroRecalls & reported problems across all models

We found 4 models of Fusion Quattro by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Apr 8, 2016 and Aug 17, 2026 — classified as 3 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Fusion Quattro problems

Fusion Quattro models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Fusion Quattro G48225

  CATHETER, BILIARY, SURGICAL
  22 reports
• Fusion Quattro G31922

  CATHETER, BILIARY, SURGICAL
  5 reports
• Fusion Quattro G31921

  CATHETER, BILIARY, SURGICAL
  4 reports
• Fusion Quattro G48226

  CATHETER, BILIARY, SURGICAL
  3 reports

Recent Fusion Quattro adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280280 ↗
• MalfunctionMar 26, 2026Material Rupture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] THE BALLOON COULD BE HEARD AUDIBLY POPPING ON FIRST ATTEMPT TO TRAWL STONES. INITIALLY THIS WAS PUT DOWN TO A SHARP STONE BEING TRAWLED BUT ON INSPECTION IT APPEARED THERE IS NO BALLOON REMAINING ATTACHED TO THE CATHETER [SUBJECT OF REPORT]. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705840 ↗
• MalfunctionMar 5, 2026Material Rupture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED THREE COOK FUSION QUATTRO EXTRACTION BALLOONS. IT WAS INITIALLY REPORTED [THAT] BALLOONS HAD [MALFUNCTIONED]. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. UPON INVESTIGATION OF RETURNED DEVICE ON 10FEB2026, IT WAS FOUND THAT DEVICE #2 AND #3 APPEARED TO HAVE PIECES MISSING [SUBJECT OF REPORT]. ALTHOUGH IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY, THE LOCATION OF THE MISSING BALLOON PIECES 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519156 ↗
• MalfunctionDec 31, 2025Material Rupture; Material Rupture

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] BALLOON HAD BURST. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. UPON INVESTIGATION OF RETURNED DEVICE ON 08DEC2025, IT WAS FOUND THAT THE BALLOON WAS MISSING PIECES [SUBJECT OF REPORT]. ALTHOUGH IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY, THE LOCATION OF THE MISSING BALLOON PIECES 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935633 ↗
• MalfunctionDec 29, 2025Material Rupture; Material Rupture

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] BALLOON HAD BURST. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. UPON INVESTIGATION OF RETURNED DEVICE ON 03DEC2025, IT WAS FOUND THAT THE BALLOON WAS 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 23912979 ↗
• MalfunctionDec 22, 2025Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE, SO [PHYSICIAN] USED FORCE TO PULL IT OUT AND CHANGED TO COMPETITOR BRAND BALLOON TO COMPLETE THE PROCEDURE. 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 23871946 ↗
• InjuryDec 10, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] THE BALLOON BURST WHILE IN USE. CUSTOMER WAS ADVISED THAT THE CASE RESULTED IN PANCREATITIS [SUBJECT OF REPORT] AND PATIENT DIED FOLLOWING THE PROCEDURE. AFTER MEETING WITH PHYSICIAN AND INVESTIGATION COMPLETED BY CORONER, THE FINDINGS WERE THAT THE EXTRACTION BALLOONS DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH THE DEATH AND WAS CONCLUDED DUE TO BE ATTRIBUTED TO OTHER FACTORS OUTSIDE OF THE PROCEDURE. IT WAS REPORTED THAT NO BALLOON FRAGMENTS WERE RETAINED IN THE PATIENT, AND THE PANCREATIC DUCT WAS NOT CANNULATED. THE MOST PLAUSIBLE ETIOLOGY FOR THE PANCREATITIS REMAINS THAT THE PATIENT EXPERIENCED STANDARD POST-ERCP PANCREATITIS, A KNOWN COMPLICATION OF THE ERCP PROCEDURE. THEREFORE, THE LIKELIHOOD THAT THE BALLOON MALFUNCTION CAUSED OR CONTRIBUTED TO THE PANCREATITIS IS CONSIDERED LOW. THIS MDR IS BEING SENT TO CAPTURE THE CLINICAL SITUATION OF PANCREATITIS.

  Patient problems: Pancreatitis

  MAUDE report 23770874 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 15, 2025Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. AS SUCH, WHEN DEFLATING THE BALLOON, THE STOP COCK WAS TURNED, THE SYRINGE WAS NOT REMOVED AND THE BALLOON WAS STILL PARTIALLY INFLATED. SINCE NO STONES WERE SEEN ON CONTRAST IMAGING, THE TEAM DECIDED TO STOP THE PROCEDURE. 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 23057497 ↗
• 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 ↗
• MalfunctionApr 25, 2025Material Rupture; Material Rupture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) , THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] THE BALLOON POPPED ON THE SECOND OR THIRD SWEEP IN THE COMMON BILE DUCT [NO REPORTABLE INFORMATION AT THIS TIME]. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THE DEVICE WAS RECEIVED FOR EVALUATION ON 01APR2025. IT WAS DETERMINED THAT THE BALLOONS APPEARS TO BE MISSING A SECTION [SUBJECT OF REPORT]. THE DETACHED BALLOON SECTION LOCATION IS UNKNOWN; IT MAY HAVE 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 21913330 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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