Jagwire™ Revolution M00557000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729962403), received between Jun 4, 2025 and Jul 29, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE REVOLUTION WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, UPON TRYING TO REMOVE THE GUIDEWIRE FROM THE TOME, RESISTANCE WAS FELT AND UPON PULLING THE WIRE, IT BROKE. IT WAS REPORTED THAT THE CORE WIRE BROKE INTO TWO SEPARATE PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646877 ↗
• InjuryJun 4, 2025Defective Device; Defective Device

  NOTE: THIS REPORT PERTAINS TO TWO JAGWIRE REVOLUTION, DREAMTOME AND AN AUTOTOME RX 39 DEVICE THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE REVOLUTION WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT CANNULATE WITH A DREAMTOME. THE PHYSICIAN SWITCHED TO A JAGWIRE REVOLUTION IN AN AUTOTOME RX 39. THE PHYSICIAN PERFORMED A WIRE GUIDED CANNULATION, AND THE WIRE APPEARED TO BE IN THE DUCT. WHEN THE CONTRAST WAS INJECTED, IT APPEARED THAT THE WIRE MAY HAVE PERFORATED THE DUCT. THE PHYSICIAN THEN WENT BACK TO DREAMWIRE BUT IT APPEARED TO FOLLOW THE SAME PATH. IT WAS REPORTED THAT THE WIRE IS STIFF AND THERE IS A LACK OF FEEL IF IT IS PERFORATING. THE PROCEDURE WAS DISCONTINUED, AND THE PATIENT WAS SENT TO IR (INTERVENTIONAL RADIOLOGY). THERE PATIENT'S CURRENT CONDITION IS GOOD AND EXPECTED TO FULLY RECOVER.

  Patient problems: Perforation

  MAUDE report 22146815 ↗
• InjuryJun 4, 2025Defective Device; Nonstandard Device; Defective Device

  NOTE: THIS REPORT PERTAINS TO TWO JAGWIRE REVOLUTION, DREAMTOME AND AN AUTOTOME RX 39 DEVICE THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE REVOLUTION WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT CANNULATE WITH A DREAMTOME. THE PHYSICIAN SWITCHED TO A JAGWIRE REVOLUTION IN AN AUTOTOME RX 39. THE PHYSICIAN PERFORMED A WIRE GUIDED CANNULATION, AND THE WIRE APPEARED TO BE IN THE DUCT. WHEN THE CONTRAST WAS INJECTED, IT APPEARED THAT THE WIRE MAY HAVE PERFORATED THE DUCT. THE PHYSICIAN THEN WENT BACK TO DREAMWIRE BUT IT APPEARED TO FOLLOW THE SAME PATH. IT WAS REPORTED THAT THE WIRE IS STIFF AND THERE IS A LACK OF FEEL IF IT IS PERFORATING. THE PROCEDURE WAS DISCONTINUED, AND THE PATIENT WAS SENT TO IR (INTERVENTIONAL RADIOLOGY). THERE PATIENT'S CURRENT CONDITION IS GOOD AND EXPECTED TO FULLY RECOVER.

  Patient problems: Perforation

  MAUDE report 22146813 ↗