Fusion G31522Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002315228), received between Jan 5, 2018 and Aug 17, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Break

  During an endoscopic retrograde cholangiopancreatography (ERCP) procedure, the physician used a Cook Fusion Wire Guide Locking Device. It was initially reported that there was a product failure. There was no reportable information at this time.On 21 Jul 2026 additional information was received stating that when securing the wire guide, one of the arms of the device broke. Then they use another Wire Guide Locking Device. "[Unable to lock wire guide]".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 50280010 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279912 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279833 ↗
• MalfunctionApr 17, 2026Accessory Incompatible; Use of Device Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION WIRE GUIDE LOCKING DEVICE. IT WAS REPORTED THAT THE DEVICE FELL APART DURING USE. THE SPONGE AND SEALS ALL CAME APART FROM THE PLASTIC HANDLE. THE SPONGE FELL DOWN THE SCOPE AND INTO THE PATIENT [SUBJECT OF REPORT]. THEY HAD TO FISH THE SPONGE OUT OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THE FOAM PIECE FELL DOWN THE SCOPE AND INTO THE PATIENT. IT WAS NOT SPECIFIED HOW IT WAS RETRIEVED, BUT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 24912981 ↗
• MalfunctionJul 9, 2025Accessory Incompatible; Accessory Incompatible

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION WIRE GUIDE LOCKING DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS IMPOSSIBLE TO PASS THE MATERIAL [ACCESSORY] THROUGH THE BLOCKER [WIRE LOCK] (TEST WITH SEVERAL PIECES OF MATERIAL). THEN THE BLOCKER [WIRE LOCK] WAS CHANGED, AND THEN IT WAS OK. CLINICAL CONSEQUENCES: DISRUPTION OF THE ERCP PROCEDURE, MOBILIZATION OF THE GUIDE WIRE WHICH DID NOT REMAIN IN PLACE WHEN THE BLOCKER [WIRE LOCK] WAS CHANGED. [LOSS OF WIRE GUIDE ACCESS]. 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 22458745 ↗
• MalfunctionJan 5, 2018Material Separation; Material Separation

  A MEDWATCH REPORT MW5073533 WAS RECEIVED ON 12/11/2017: THE PATIENT WAS UNDERGOING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND IT WAS NOTED THAT A SPONGE WAS IN THE BIOPSY CHANNEL FROM A PREVIOUS PROCEDURE. IT IS BELIEVED THAT THE SPONGE MATERIAL MACHINES [MATCHES] THAT OF THE BIOPSY CAP. THE SCOPE WAS REMOVED AND NEW SCOPE WAS UTILIZED. THE PATIENT REQUIRED NO FURTHER TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 01/03/2017: THE REPORTERS WERE NOT CERTAIN IF THE LOCKING DEVICE WAS FROM COOK. IT WAS QUITE POSSIBLY [THE BOSTON SCIENTIFIC] LOCKING DEVICE BECAUSE THEY USE BOTH. THE REPORTER SAID SHE HAS SENT ALL THE INFORMATION TO RISK MANAGEMENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7167952 ↗