Dreamwire M00556140Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729779582), received between Nov 16, 2020 and Nov 18, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Break; Failure to Advance

  FROM STAFF: LONG WIRE WOULD NOT ADVANCE IN DREAMTOME; DREAMTOME BROKE AT TIP OF END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582055 ↗
• MalfunctionNov 16, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS REPORT PERTAINS TO A DREAMWIRE MANUFACTURER REPORT# JAGWIRE REVOLUTION 3005099803-2020-05391 USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE REVOLUTION AND A DREAMWIRE GUIDEWIRE WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC ULTRASOUND (EUS) GUIDED RENDEZVOUS PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A NON BOSTON SCIENTIFIC EUS NEEDLE WENT THROUGH THE STOMACH AND GAINED ACCESS INTO THE INTRAHEPATIC DUCTS. A DREAMWIRE WAS USED HOWEVER NO ISSUES WERE REPORTED WITH THIS GUIDEWIRE. WHEN TRYING TO ADVANCE THE JAGWIRE REVOLUTION INTO THE COMMON BILE DUCT TO EXIT THE AMPULLA THE PTFE PORTION OF THE JAGWIRE REVOLUTION DETACHED IN THE LEFT DUCT. THE PROCEDURE WAS CANCELLED SINCE ACCESS WAS LOST WHILE CANNULATING. REPORTEDLY, PATIENT WENT TO IR (INTERVENTIONAL RADIOLOGY), BUT IT WAS NOT PRIMARILY TO REMOVE THE PORTION THAT DETACHED BUT RATHER TO PERFORM PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC). THE IFU FOR DREAMWIRE AND JAGWIRE REVOLUTION STATES THE FOLLOWING: DO NOT USE WITH METAL-TIP CATHETERS. WITHDRAWING THE GUIDEWIRE THROUGH A METAL TIP CATHETER MAY DAMAGE THE SURFACE OF THE GUIDEWIRE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10842738 ↗