Fusion G31532Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002315327), received between Oct 31, 2016 and Jun 8, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2022Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use

  DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION, THE PHYSICIAN USED A COOK FUSION BILIARY DILATION BALLOON. IT WAS REPORTED [THAT] THE USER ATTEMPTED TO INFLATE THE BALLOON AT THE PAPILLA FOR DILATATION, BUT THE BALLOON WOULD NOT INFLATE. LEAKAGE OF CONTRAST MEDIA FROM BALLOON WAS OBSERVED. THERE IS NO INFORMATION HOW THE PLANNED PROCEDURE FINISHED AFTER THIS EVENT OCCURRED. 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 14637117 ↗
• MalfunctionAug 30, 2019Fluid/Blood Leak; Off-Label Use; Use of Device Problem; Fluid/Blood Leak; Off-Label Use; Use of Device Problem

  DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE [OFF LABEL USE], THE PHYSICIAN USED A COOK FUSION BILIARY DILATION BALLOON. THE BALLOON WAS DELIVERED TO THE TARGET SITE ALONG A 0.025 INCH WIRE GUIDE. WHEN THE BALLOON CATHETER [BALLOON] WAS INFLATED, IT WAS CONFIRMED THAT THE PRESSURE FOR THE BALLOON CATHETER [BALLOON] COULD NOT RISE [UNABLE TO INFLATE]. THE DAMAGE OF THE BALLOON CATHETER [BALLOON MATERIAL] WAS CONFIRMED AFTER CONTRAST AND SALINE WERE GONE [BALLOON LEAKED]. 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 Consequences Or Impact To Patient

  MAUDE report 8952373 ↗
• MalfunctionAug 30, 2019Fluid/Blood Leak; Off-Label Use; Use of Device Problem; Fluid/Blood Leak; Off-Label Use; Use of Device Problem

  DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE [OFF LABEL USE], THE PHYSICIAN USED A COOK FUSION BILIARY DILATION BALLOON. THE BALLOON WAS DELIVERED TO THE TARGET SITE ALONG A 0.025 INCH WIRE GUIDE. THE BALLOON WAS DAMAGED. THE DEVICE WAS RECEIVED FOR EVALUATION ON (B)(6) 2019.THE BALLOON WOULD NOT HOLD PRESSURE AND A LEAKAGE WAS SEEN FROM TWO PINHOLES IN THE BALLOON. 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 Consequences Or Impact To Patient

  MAUDE report 8952360 ↗
• MalfunctionAug 30, 2019Fluid/Blood Leak; Off-Label Use; Use of Device Problem; Fluid/Blood Leak; Off-Label Use; Use of Device Problem

  DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE [OFF LABEL USE], THE PHYSICIAN USED A COOK FUSION BILIARY DILATION BALLOON. THE BALLOON WAS DELIVERED TO THE TARGET SITE ALONG A 0.025 INCH WIRE GUIDE. WHEN THE BALLOON CATHETER [BALLOON] WAS INFLATED, IT WAS CONFIRMED THAT THE PRESSURE FOR THE BALLOON CATHETER [BALLOON] COULD NOT RISE [UNABLE TO INFLATE]. THE DAMAGE OF THE BALLOON CATHETER [BALLOON MATERIAL] WAS CONFIRMED AFTER CONTRAST AND SALINE WERE GONE [BALLOON LEAKED]. 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 Consequences Or Impact To Patient

  MAUDE report 8952359 ↗
• MalfunctionFeb 14, 2018Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method; Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method

  DURING AN ENDOSCOPIC BILIARY TRACT DILATION, THE PHYSICIAN CHOSE A COOK FUSION BILIARY DILATION BALLOON. THERE WAS NO SPECIFIC TORTUOSITY IN THE PATIENT ANATOMY. THE DEVICE WAS ADVANCED OVER ANOTHER MANUFACTURER'S WIRE GUIDE FOR PAPILLARY DILATION, BUT THE BALLOON DID NOT INFLATE AT THE FIRST ATTEMPT OF DILATION. THEREFORE, IT WAS CHANGED WITH ANOTHER SIZED COOK DILATION BALLOON. THE PROCEDURE WAS COMPLETED, AND THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 01/31/2018. THE BALLOON JOINT WAS FOUND TO HAVE FAILED AND THE BALLOON MOVED TOWARD THE DISTAL END OF THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7269460 ↗
• MalfunctionDec 8, 2016Hole In Material; Off-Label Use; Hole In Material; Off-Label Use

  DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE, THE PHYSICIAN USED A COOK FUSION BILIARY DILATION BALLOON. THE USER INSERTED A FUSION BILIARY DILATION BALLOON INTO THE PAPILLA AND APPLIED PRESSURE, BUT THE BALLOON WOULD NOT INFLATE TO THE DESIRED SIZE. IT WAS REPLACED WITH ANOTHER MANUFACTURER'S BALLOON CATHETER TO COMPLETE THE PROCEDURE. A PICTURE OF THE BALLOON WAS PROVIDED ON 11/16/2016. THIS PICTURE SHOWS A PINHOLE IN THE BALLOON, IMPLYING LEAKAGE OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6155934 ↗
• MalfunctionOct 31, 2016Hole In Material; Off-Label Use; Use of Device Problem; Hole In Material; Off-Label Use; Use of Device Problem

  DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE, THE PHYSICIAN USED ONE (1) FUSION BILIARY DILATION BALLOON BEFORE LITHOTOMY. IT WAS NOTICED THAT THERE WAS A PINHOLE ON THE BALLOON DURING THE FIRST DILATION OF THE BALLOON. ANOTHER DEVICE [OF THE SAME TYPE] WAS USED INSTEAD, HOWEVER A PINHOLE ON THE BALLOON WAS NOTICED ON THE SECOND DEVICE AS WELL. [SEE RELATED MDR REPORT NUMBER 1037905-2016-00432]. THE PRESSURE OF THE BALLOON DECREASED DUE TO THE PINHOLE, SO THE LESION WAS NOT DILATED ENOUGH. HOWEVER SINCE THE LESION WAS DILATED A LITTLE, DILATION PROCEDURE WAS COMPLETE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6067467 ↗
• MalfunctionOct 31, 2016Hole In Material; Off-Label Use; Use of Device Problem; Hole In Material; Off-Label Use; Use of Device Problem

  DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD), THE PHYSICIAN USED ONE (1) FUSION BILIARY DILATION BALLOON BEFORE LITHOTOMY. IT WAS NOTICED THAT THERE WAS A PINHOLE ON THE BALLOON DURING THE FIRST DILATION OF THE BALLOON. ANOTHER DEVICE WAS USED INSTEAD, HOWEVER A PINHOLE ON THE BALLOON WAS NOTICED ON THE SECOND DEVICE AS WELL. [SEE RELATED MDR REPORT NUMBER 1037905-2016-00434]. THE PRESSURE OF THE BALLOON DECREASED DUE TO THE PINHOLE, SO THE LESION WAS NOT DILATED ENOUGH. HOWEVER SINCE THE LESION WAS DILATED A LITTLE, DILATION PROCEDURE WAS COMPLETE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6067375 ↗