Fusion G57301Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002573014), received between Sep 21, 2021 and Mar 29, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 29, 2022Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT 2 WIRE GUIDE. IT WAS INITIALLY REPORTED THAT THE TIP OF THE DEVICE CAME OUT OF STERILE PACKING SLIGHTLY BENT CAUSING ORIENTATION ISSUES. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE ON 28 FEBRUARY 2022 DETERMINED THAT THE ANCHOR HAD SEPARATED FROM THE CATHETER AND A PORTION DETACHED. [SUBJECT OF REPORT] IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; THE LOCATION OF THE MISSING PORTION 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 13939143 ↗
• MalfunctionNov 11, 2021Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT 2 WIRE GUIDE. IT WAS INITIALLY REPORTED THAT THE [CUTTING] WIRE SNAPPED UPON CUTTING MID PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE ON 10/14/2021 DETERMINED THAT THE ANCHOR HAD SEPARATED FROM THE TIP. 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 12797048 ↗
• MalfunctionSep 21, 2021Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT 2 WIRE GUIDE. THE WIRE IN THE SPHINCTEROTOME FRACTURED AT THE PROXIMAL END AND WHEN REMOVED, THE WIRE HAD COMPLETELY DETACHED. THE USER STATED THAT "PROXIMAL 5CM OF WIRE" REMAINED IN THE PATIENT; HOWEVER, THE TOTAL LENGTH OF THE CUTTING WIRE IS APPROXIMATELY 2.5 CM. A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO INFORMATION WAS PROVIDED AS TO HOW OR IF THE CUTTING WIRE WAS RETRIEVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506927 ↗