Jagtome Revolution RXRecalls & reported problems across all models

We found 3 models of Jagtome Revolution RX by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Mar 19, 2020 and Aug 13, 2026 — classified as 2 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Break” (55 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Jagtome Revolution RX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0767-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

2. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0766-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

3. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0765-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported Jagtome Revolution RX problems

Jagtome Revolution RX models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Jagtome™ Revolution RX M00584240

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall42 reports
• Jagtome™ Revolution RX M00584260

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall28 reports
• Jagtome™ Revolution RX M00584250

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports

Recent Jagtome Revolution RX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Break; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50244651 ↗
• MalfunctionMay 6, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE WIRE BROKE ALONG THE WORKING LENGTH WHEN SPHINCTEROTOMY WAS INITIATED. 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 AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094003 ↗
• MalfunctionApr 14, 2026Failure to Fold; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN (B)(6) 0F 2026. DURING THE PROCEDURE, IT WAS FOUND THAT THE CUTTING WIRE ON THE SPHINCTEROTOME WAS BENT AFTER THE DEVICE WAS ALREADY INSIDE THE PATIENT. THE PHYSICIAN DECLINED TO CHANGE THE DEVICE AS THE CAUTERY WORKED WITH THE TOME; THEY WERE JUST UNABLE TO BOW/BEND THE TOME ALL THE WAY. THE PROCEDURE WAS STILL COMPLETED USING THE SAME ORIGINAL DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876110 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHILE USING CAUTERY. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE 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 24654024 ↗
• MalfunctionFeb 27, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WIRE BROKE OFF CATHETER WHILE THEY WERE ABOUT TO USE CAUTERY. THE CUTTING WIRE WAS INTACT, BUT THE WIRE ANCHOR DISLODGED FROM THE CATHETER. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471424 ↗
• MalfunctionFeb 2, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THEY TRIED TO BOW THE TOME AND THE WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE 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 24242425 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT DEVICE WAS BROKEN AND DID NOT WORK RIGHT FROM THE START. ADDITIONAL CLARIFICATION TO DETERMINE THE NATURE OF THE DAMAGE WAS NOT PROVIDED AND IS BEING REPORTED AS THE CUTTING WIRE MAY HAVE BEEN BROKEN. NO FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127170 ↗
• MalfunctionJan 5, 2026Break; Deformation Due to Compressive Stress

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO JAGTOME REVOLUTION RX USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, CUTTING WIRE BENT IN HALF AND COULDN'T BE USED FOR SPHINCTEROTOMY. IT WAS ALSO REPORTED THAT THE WIRE ANCHOR WAS DISLODGED FROM THE CATHETER. A SECOND JAGTOME REVOLUTION RX WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT NO PART OF THE DEVICE 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. IT WAS REPORTED THAT THE PATIENT CONDITION WAS FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 26, 2026: IT WAS REPORTED THAT ONLY ONE JAGTOME REVOLUTION RX HAD A WIRE ANCHOR DETACHED AND THE PROCEDURE WAS COMPLETED WITH THE SECOND OF THE SAME DEVICE. THE ANATOMY LOCATION INVOLVED WAS THE DUODENUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959972 ↗
• MalfunctionJan 5, 2026Break; Deformation Due to Compressive Stress

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO JAGTOME REVOLUTION RX USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, CUTTING WIRE BENT IN HALF AND COULDN'T BE USED FOR SPHINCTEROTOMY. IT WAS ALSO REPORTED THAT THE WIRE ANCHOR WAS DISLODGED FROM THE CATHETER. A SECOND JAGTOME REVOLUTION RX WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT NO PART OF THE DEVICE 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. IT WAS REPORTED THAT THE PATIENT CONDITION WAS FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 26, 2026: IT WAS REPORTED THAT ONLY ONE JAGTOME REVOLUTION RX HAD A WIRE ANCHOR DETACHED AND THE PROCEDURE WAS COMPLETED WITH THE SECOND OF THE SAME DEVICE. THE ANATOMY LOCATION INVOLVED WAS THE DUODENUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959962 ↗
• MalfunctionDec 30, 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 RX 39 WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE INTRAOPERATIVELY INSIDE THE PATIENT. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924130 ↗
• MalfunctionAug 23, 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 RX WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, 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 JAGTOME REVOLUTION RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22880285 ↗
• MalfunctionAug 15, 2025Failure to Align; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Failure to Align; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED AND BOWED CORRECTLY BUT THE CUT WIRE ORIENTATION OUT OF THE SCOPE WAS OUT OF POSITION. AN ATTEMPT WAS MADE TO MANIPULATE THE TOME BY ROTATING THE HANDLE WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME REVOLUTION RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF DEVICE CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813056 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME REVOLUTION RX 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 22778231 ↗
• MalfunctionJul 28, 2025Break; Peeled/Delaminated; Material Deformation; Break; Peeled/Delaminated; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A JAGTOME REVOLUTION RX WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE TECH STRIPS THE WIRE TO THE PHYSICIAN, THE COATING OF THE GUIDEWIRE PEELED. THE CUTTING WIRE ALSO BROKE INSIDE THE DUCT. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC GUIDEWIRE AND A DIFFERENT SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED. ADDITIONALLY, THE PTFE COATING OF THE GUIDEWIRE WAS ALSO PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639486 ↗
• MalfunctionMar 21, 2025Failure to Align; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Failure to Align; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME REVOLUTION RX WAS ATTEMPTED TO BE USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED THROUGH A DUODENOSCOPE. THE TECHNICIAN NOTED THAT THE SPHINCTEROTOME WAS ALREADY IN A BOWED POSITION, AND THE HANDLE WAS UNABLE TO ADJUST THE BOW ANGLE WHEN MOVED. IT WAS REPORTED THAT THE DEVICE COULD NOT BE UNBOWED OR RELEASED FROM THE BOWING POSITION. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME REVOLUTION RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665694 ↗

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