Jagtome™ Revolution Pro RX 39 M00584470Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00191506039318), received between May 16, 2024 and Sep 20, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50833678 ↗
• MalfunctionSep 3, 2026Break; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599384 ↗
• InjuryMay 12, 2026Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A JAGTOME REVOLUTION PRO RX 39 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND STENT PLACEMENT PROCEDURE TO TREAT COMMON BILE DUCT (CBD) BLOCKAGE BY A PANCREATIC MASS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PATIENT WAS FOUND TO HAVE A CBD OBSTRUCTION CAUSED BY EXTRINSIC COMPRESSION FROM A PANCREATIC MASS. INITIAL CANNULATION WAS ATTEMPTED USING A NON-BSC DEVICE FOR APPROXIMATELY 25 MINUTES BUT WAS UNSUCCESSFUL. THE DEVICE WAS THEN CHANGED TO A JAGTOME REVOLUTION RX 39, AND CANNULATION WAS ATTEMPTED FOR AN ADDITIONAL 10 MINUTES. DURING THESE ATTEMPTS, THE GUIDEWIRE REPEATEDLY MET RESISTANCE TO CANNULATE INTO THE PANCREATIC DUCT. A PERFORATION OCCURRED WHEN THE GUIDEWIRE LOOPED BACK ON ITSELF AND PENETRATED THE WALL OF THE COMMON BILE DUCT AND MUCOSA, ENTERING THE DUODENAL LUMEN WITHOUT PASSING THROUGH THE SPHINCTER. PROPHYLACTIC TREATMENT WAS ADMINISTERED BY GIVING THE PATIENT INDOMETHACIN AFTER HAVING REPEATEDLY CANNULATED INTO THE PANCREATIC DUCT AS A METHOD OF PREVENTING OR ALLEVIATING THE ONSET OF POST ERCP PANCREATITIS. DUE TO THE PERFORATION AND ASSOCIAT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 25145922 ↗
• MalfunctionMar 30, 2026Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION PRO RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. PRIOR TO THE PROCEDURE, THE JAGTOME WAS UNABLE TO ADVANCE THROUGH THE SCOPE DUE TO BENT IN DISTAL TIP OF WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736963 ↗
• MalfunctionDec 30, 2025Break; Use of Device Problem; Deformation Due to Compressive Stress; Break; Use of Device Problem; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION PRO RX 39 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE PERFORMING SPHINCTEROTOMY AND BOW FEATURE OF THE DEVICE WAS ENGAGED, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931466 ↗
• MalfunctionJul 8, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION PRO RX 39 WAS ATTEMPTED TO BE USED IN THE PANCREATICOBILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT OBSTRUCTION PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WIRE BROKE WHERE THE INSULATED COVER MEETS THE WIRE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436295 ↗
• MalfunctionMar 24, 2025Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION PRO RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE WOULD NOT UNBOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME REVOLUTION PRO RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21683321 ↗
• MalfunctionFeb 23, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION PRO RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, AS THEY WERE GETTING READY TO CUT, THE CUTTING WIRE OF THE JAGTOME REVOLUTION PRO RX 39 BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442798 ↗
• MalfunctionJan 10, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION PRO RX 39 WAS BEING PREPARED FOR USE IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED ON (B)(6) 2024. DURING PREPARATION, UPON OPENING THE PACKAGE, IT WAS OBSERVED THAT THE CUTTING WIRE OF THE TOME WAS BROKEN BEFORE BEING USED. A PHOTO OF THE DEVICE INSIDE THE POUCH WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE CUTTING WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME REVOLUTION PRO RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123717 ↗
• MalfunctionNov 14, 2024Failure to Align; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Failure to Align; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION PRO RX 39 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHIELDING ON THE CUT WIRE WAS SEPARATED FROM THE CUT WIRE AFTER CANNULATION OF THE COMMON BILE DUCT. REPORTEDLY, THE DEVICE BOWED CORRECTLY HOWEVER IT WOULD NOT RELEASE THE BOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE INSULATION WAS DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683818 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO TWO JAGTOME REVOLUTION PRO RX 39 AND AN EXTRACTOR PRO RETRIEVAL BALLOON USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION PRO RX 39 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN UNINTENTIONALLY CANNULATED THE PANCREATIC DUCT THREE TIMES, BUT WAS ABLE TO SUCCESSFULLY CANNULATE THE COMMON BILE DUCT. CONTRAST WAS INJECTED AND A NORMAL COMMON BILE DUCT WAS VISUALIZED. THE SPHINCTEROTOME WAS THEN PULLED BACK TO PERFORM SPHINCTEROTOMY. THE PHYSICIAN HAD THE INSULATED PORTION OF THE CUT WIRE TRAVERSING THE AMPULLA ORIFICE BUT CONTINUED TO APPLY UPWARD FORCE AND CAUTERY. THERE WAS BLEEDING BEYOND THE AMPULLA THROUGHOUT THE REST OF THE CASE. THE PHYSICIAN THEN REMOVED THE SPHINCTEROTOME AND AN EXTRACTOR PRO RETRIEVAL BALLOON WAS ADVANCED OVER THE GUIDEWIRE WITHOUT DIFFICULTY UNTIL HE ENTERED THE PROXIMAL CBD AT WHICH POINT HE WAS NOT ABLE TO ADVANCE THE BALLOON ANY FURTHER. EVENTUALLY, THE BALLOON WAS REMOVED AND WHILE WAITING FOR THE NEXT BALLOON THE PHYSICIAN LOST ACCESS TO THE CB

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 19334609 ↗