Jagtome RX 39Recalls & reported problems across all models

We found 4 models of Jagtome RX 39 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2017 and Aug 31, 2026 — classified as 1 injury, 55 malfunctions.

The most frequently reported specific device problem is “Break” (41 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 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 RX 39 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-0772-2022 · 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-0771-2022 · 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-0770-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

4. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0769-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

5. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0768-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported Jagtome RX 39 problems

Jagtome RX 39 models

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

• Jagtome RX 39 M00573110

  Unit, electrosurgical, endoscopic (with or without accessories)
  2 recalls0 reports
• Jagtome RX 39 M00573080

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall35 reports
• Jagtome RX 39 M00573100

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall19 reports
• Jagtome RX 39 M00573090

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall2 reports

Recent Jagtome RX 39 adverse event reports

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

• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533778 ↗
• MalfunctionMay 22, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS PREPARED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALL STONES PERFORMED ON (B)(6) 2026. DURING PREPARATION, THE PHYSICIAN INSPECTED THE TOME AND NOTED THAT THE WIRE WAS EXCESSIVELY BENT. THE NURSE ATTEMPTED TO OPEN THE HANDLE TO ADJUST THE TOME, BUT THE WIRE COULD NOT BE STRAIGHTENED FURTHER. THE CUSTOMER PROVIDED A PICTURE WHERE IT WAS POSSIBLE TO OBSERVE THE DEVICE WAS ON A SEMI BOWED STATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25251476 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE TOME WAS USED TO MAKE THE INITIAL CUT. WHEN IT WAS OPENED AGAIN TO PERFORM A SECOND CUT, THE CUTTING WIRE WAS FOUND TO BE ALREADY SPLIT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590207 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE TOME WAS BOWED AND CAUTERY WAS ACTIVATED TO PERFORM THE SPHINCTEROTOMY WHEN THE CUT 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 DUE TO THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545571 ↗
• MalfunctionJan 13, 2026Break; Failure to Fold; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR STONE MANAGEMENT PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 39 BROKE WHEN BOWING WAS PERFORMED. IT WAS REPORTED THAT THE HANDLE OF THE DEVICE WAS ALSO DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052405 ↗
• MalfunctionDec 26, 2025Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE DUODENUM AND AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR BILE DUCT ASSESSMENT PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED CANNULATION USING THE DEVICE. THE TOME APPEARED BOWED, AND THE PHYSICIAN INSTRUCTED THE NURSE TO FULLY OPEN THE HANDLE. DESPITE THIS, THE DEVICE REMAINED ENGAGED. THE TOME WAS SUBSEQUENTLY REMOVED, AND INSPECTION REVEALED THAT THE CUT WIRE WAS PARTIALLY BOWED AND COULD NOT STRAIGHTEN EVEN WITH THE HANDLE FULLY OPENED. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897937 ↗
• MalfunctionDec 24, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) AND PANCREATIC DUCT (PD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH MAC SEDATION FOR PANCREATIC MASS AND BILIARY OBSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE COMMON BILE DUCT AND PANCREATIC DUCT WERE CANNULATED WITH GUIDEWIRE, CHOLANGIOGRAM PERFORMED AND THEN SPHINCTEROTOMY PERFORMED. DURING SPHINCTEROTOMY, IT WAS NOTED THAT ONE END OF THE CUTTING WIRE ON THE SPHINCTEROTOME HAD BECOME DETACHED. THE TOME WAS IMMEDIATELY REMOVED THROUGH THE SCOPE. AT THIS POINT, THE DOCTOR WAS SATISFIED WITH THE EXTENT OF THE SPHINCTEROTOMY, SO NO NEW TOME WAS REQUIRED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CONTINUED WITH ADDITIONAL CHOLANGIOGRAM, BALLOON SWEEPS AND STENT PLACEMENT. BLEEDING FROM MOUTH NOTED DURING THE PROCEDURE. ANESTHESIA EVALUATED AND DETERMINED THE PATIENT TO BE STABLE WITH NO VENTILATION IMPAIRMENT, SO ERCP WAS COMPLETED. POST ERCP AN ESOPHAGOGASTRODUODENOSCOPY (EGD) SCOPE WAS REINTRODUCED TO EVALUATE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889193 ↗
• MalfunctionDec 24, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT JAUNDICE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 39 SPHINCTEROTOME SNAPPED WHEN THE TOME WAS ENERGIZED AND BOWED. A SECOND JAGTOME RX 39 WAS USED, BUT THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A THIRD JAGTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886419 ↗
• MalfunctionDec 24, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT JAUNDICE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 39 SPHINCTEROTOME SNAPPED WHEN THE TOME WAS ENERGIZED AND BOWED. A SECOND JAGTOME RX 39 WAS USED, BUT THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A THIRD JAGTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886418 ↗
• MalfunctionOct 21, 2025Failure to Fold; Failure to Align; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Failure to Fold; Failure to Align; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS ATTEMPTED TO BE USED IN THE BILE DUCTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE EXTRACTION PROCEDURE TO TREAT STONES IN THE BILE DUCTS PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE DEVICE WAS UNABLE TO BE INSERTED INTO THE SCOPE. PHYSICIAN NOTICED THAT THE TIP WAS BENT, UNABLE TO BOW, AND BOWING OUT OF PLANE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348719 ↗
• MalfunctionOct 1, 2024Break; 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 RX 39 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE BROKE IN HALF. 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 20346524 ↗
• MalfunctionFeb 22, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE JAGTOME RX 39 WOULD NOT BOW. THE HANDLE LOOKED FINE AND MULTIPLE TACTICS WERE TRIED TO GET IT BOWED, AND THEN IT WAS NOTICED THAT THE CUTTING WIRE WAS ALREADY BROKEN, THAT'S WHY IT DID NOT BOW. 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: NOTE: IT WAS REPORTED THAT THE DEVICE ENERGIZED PRIOR TO BOWING; HOWEVER, PER THE INSTRUCTIONS FOR USE (IFU), "PRECAUTION: THE SPHINCTEROTOME DOES NOT NEED TO BE ENERGIZED PRIOR TO PERFORMING SPHINCTEROTOMY. ENERGIZING THE CUTTING WIRE PRIOR TO USE WILL CAUSE PREMATURE CUTTING WIRE FATIGUE AND WILL COMPROMISE THE CUTTING WIRE'S INTEGRITY." ADDITIONALLY, THE DEVICE ENERGIZED WHEN NOT IN CONTACT WITH TISSUE; HOWEVER, PER THE IFU, "PRECAUTION: IT IS RECOMMENDED TO MAINTAIN DIRECT AND CONSTANT CONTACT WITH TISSUE WHEN APPLYING ELECTROCAUTERY CURRENT. FAILURE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757556 ↗
• MalfunctionJan 5, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN JAGTOME RX 39 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, ON THE FIRST ATTEMPT TO BOW THE DEVICE, THE CUTTING WIRE OF THE JAGTOME RX 39 BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE DEVICE WAS REMOVED FROM THE SCOPE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWS THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460419 ↗
• MalfunctionJan 2, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Material Integrity Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS BEING PREPARED FOR USE IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON DECEMBER 7, 2023. DURING PREPARATION, WHEN THE PACKAGING OF THE DEVICE WAS OPENED, IT WAS NOTICED THAT THE PLASTIC CATHETER WAS SPLIT, AND THE CUTTING WIRE ANCHOR WAS DISLODGED. 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 18423624 ↗
• MalfunctionMay 25, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS INTENDED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. UPON DELIVERY, IT WAS NOTICED THAT THE PACKAGING OF THE JAGTOME RX 39 WAS RIPPED AND THERE WAS A HOLE, COMPROMISING THE STERILE BARRIER. 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 17007056 ↗

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