Fusion G31537Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002315372), received between Mar 25, 2016 and Sep 24, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 24, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882444 ↗
• MalfunctionMay 11, 2026Deflation Problem

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED [THAT] THE BALLOON INFLATED NORMALLY, BUT IT WAS IMPOSSIBLE TO DEFLATE IT DESPITE SEVERAL ATTEMPTS BY DIFFERENT STAFF MEMBERS (NURSES AND PHYSICIANS). THE BALLOON REMAINED INFLATED AND VERY HARD. FINALLY, AFTER AN HOUR, THE NURSE TRIED AGAIN TO DEFLATE IT, AND THIS TIME IT WORKED. IT WAS TAKEN DEFLATED TO THE PHARMACY, AND THE PROBLEM WAS NO LONGER OBSERVED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135491 ↗
• MalfunctionApr 9, 2026Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR STONE EXTRACTION IN THE COMMON BILE DUCT, THE PHYSICIAN USED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED THAT THE BALLOON COULD NOT DEFLATE ONCE IN THE BILE DUCT. 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 24835354 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC STONE REMOVAL THE PHYSICIAN SELECTED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED [THAT] THE BALLOON LEAKED AIR AFTER INFLATION AND COULD NOT INFLATE. A NEW THREE LUMEN BALLOON WAS IMMEDIATELY REPLACED, AND THE DEVICE WAS CHECKED FOR INTEGRITY. THE WIRE GUIDE WAS EXCHANGED AGAIN AND THE STONE WAS REMOVED FROM THE COMMON BILE DUCT. DURING THIS PERIOD, THE PATIENT'S SPHINCTER INCISION BLEEDING WAS SIGNIFICANT (NORMALLY THERE SHOULD BE NO BLEEDING), AND THE PATIENT'S OXYGEN SATURATION WAS MONITORED TO DECREASE TO 86%. AFTER ANESTHESIA TREATMENT, THE OXYGEN SATURATION WAS RESTORED TO 96 [SUBJECT OF REPORT], TAKING ABOUT 15 MINUTES TO REPLACE THE EQUIPMENT AND TREAT BLOOD OXYGEN SATURATION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT EXPERIENCED BLEEDING DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S ANESTHESIA AND SURGERY TIME WERE PROLONGED.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23993484 ↗
• MalfunctionDec 29, 2025Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED [THAT] THE BALLOON WAS INFLATED AS USUAL, IT WAS PRE-TESTED PRIOR TO USE, THEN IT WAS ADVANCED INTO THE BILE DUCT TO SWIPE THE STONES, BUT AFTER THAT THE DEVICE COULDN'T BE DEFLATED. 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 23907178 ↗
• MalfunctionNov 18, 2025Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE PHYSICIAN WAS USING A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED THAT THE BALLOON INFLATED. HOWEVER, WHILE ATTEMPTING TO EXPEL THE AIR, THE BALLOON REMAINED INFLATED. AS SUCH, THE DEVICE WAS REPLACED WITH ANOTHER ONE TO CONTINUE 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 23585628 ↗
• MalfunctionNov 3, 2025Material Rupture; Material Rupture

  DURING A STONE REMOVAL PROCEDURE IN THE BILE DUCT, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS INITIALLY REPORTED THAT THE BALLOON WAS SHRINKING AND LEAKED AFTER REACHING THE TARGET LOCATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 23444795 ↗
• MalfunctionJun 23, 2025Deflation Problem; Deflation Problem

  IN PREPARATION FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED [THAT] DURING TESTING OF THE BALLOON PREVIOUS TO THE USAGE OF THE PRODUCT IN THE PATIENT, CUSTOMER INFLATED THE BALLOON AS PER MANUFACTURE INSTRUCTIONS OF USE, THE TEST WAS OK WITH NO AIR LEAKAGE, BUT THEN THE BALLOON REMAINED INFLATED [FAILED TO DEFLATE] AND THE DEVICE COULD NOT BE USED ANYMORE. CUSTOMER PROVIDED VIDEO OF BALLOON FAILING TO DEFLATE. 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 22307876 ↗
• MalfunctionMay 22, 2025Failure to Deflate; Failure to Deflate

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE COMMON BILE DUCT, THE PHYSICIAN USED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. A DUODENAL SCOPE WAS INTRODUCED AND PLACED IN THE DUODENUM. ANOTHER MANUFACTURER¿S LOCKING DEVICE WAS PLACED ON THE SCOPE. ANOTHER MANUFACTURER¿S TOME AND GUIDE WIRE WAS ALSO USED. A SPHINCTEROTOMY WAS PERFORMED ON THE PATIENT AND THE COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING WAS INTRODUCED INTO THE BILIARY DUCT. THE BALLOON WAS INFLATED AND ADVANCED INTO THE COMMON BILE DUCT. AS SUCH, ONCE THE BALLOON WAS OUT OF THE DUCT, AND IN THE DUODENUM, IT WOULD NOT DEFLATE. THE BALLOON DIDN'T DEFLATE EVEN WHEN THE INFLATION SYRINGE WAS REMOVED FROM THE NOZZLE. THE SURGEON HAD TO POP THE BALLOON. THE SURGEON REQUESTED ANOTHER EXTRACTION BALLOON AND IT WORKED WELL AND CLEARED THE DUCT OF STONES. 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 22071926 ↗
• MalfunctionJul 2, 2019Material Fragmentation; Material Fragmentation

  DURING A STONE EXTRACTION PROCEDURE, THE PHYSICIAN USED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. WHEN SWEEPING THE COMMON BILE DUCT, THE BALLOON BURST. NOTHING FROM THE DEVICE DETACHED OR CAME APART IN THE PATIENT AND THERE WAS NO HARM TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED ON 11-JUN-2019 AND THERE WERE PORTIONS OF THE BALLOON MATERIAL MISSING. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE LOCATION OF THE MISSING SECTION DETECTED DURING OUR LABORATORY EVALUATION 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 Consequences Or Impact To Patient

  MAUDE report 8756087 ↗
• MalfunctionDec 20, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN CHOSE A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. THE BALLOON COULD NOT BE INFLATED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED ON 11/30/17 AND WAS FOUND TO HAVE INTRADUCTAL EXCHANGE (IDE) PORT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133948 ↗
• MalfunctionNov 17, 2017Deflation Problem; Deflation Problem

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN CHOSE A FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. THE BALLOON WAS INFLATED TO VERIFY THE DEVICE FUNCTION. HOWEVER, BECAUSE THE BALLOON WOULD NOT DEFLATE, IT WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE AND THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7040294 ↗
• MalfunctionSep 13, 2016Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. AS REPORTED TO CUSTOMER RELATIONS: "WIRE UNRAVELED FROM BALLOON SHEATH." NO FURTHER INFORMATION WAS AVAILABLE. THE DEVICE WAS RECEIVED FOR EVALUATION ON (B)(6) 2016. IT WAS NOTICED AT THIS TIME THAT THE INNER WIRE HAD PENETRATED THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5945570 ↗
• MalfunctionJun 29, 2016Material Fragmentation; Material Fragmentation

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. THE PRODUCT WAS RECEIVED FOR EVALUATION ON 06/06/2016. AT THIS TIME, IT WAS FOUND THAT PRODUCT MATERIAL WAS MISSING. PER CLARIFICATION RECEIVED ON 06/08/2016: "BALLOON ¿BROKE¿ INSIDE THE PATIENT. I HAVE TALKED TO THE UNIT IN (B)(6) HOSPITAL AND THEY JUST REMEMBER THAT THE BALLOON ¿BROKE¿ INSIDE THE PATIENT ¿ THEY DO NOT HAVE THE LOT-NUMBER ANYMORE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5758485 ↗
• MalfunctionMar 25, 2016Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. THE WIRE OF A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME WAS STRIPPED DURING USE WITH THE COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING; THE WIRE BECAME STUCK INSIDE THE BALLOON CATHETER. THE PHYSICIAN HAD ALREADY DONE A FEW SWEEPS WITH THE BALLOON WHEN THE PROBLEM OCCURRED WITH THE BALLOON AND THE WIRE FROM THE SECOND SPHINCTEROTOME. THE CASE WAS ENDED/COMPLETE AFTER THE BALLOON BECAME STUCK ON THE WIRE. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION ON 03/01/2016, THE INTRADUCTAL EXCHANGE (IDE) PORT WAS FOUND TO BE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5525824 ↗