Jagwire M00556590Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729858546), received between Mar 1, 2018 and Nov 26, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS RECEIVED BY THE CUSTOMER ON (B)(6) 2025. IT WAS REPORTED THAT UPON OPENING, THE BEGINNING OF THE STITCHES IS TORN, REVEALING THE CONTENTS. THE PRODUCT WAS NOT USED IN A PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659786 ↗
• MalfunctionNov 11, 2020Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC BILIARY STENT PLACEMENT PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE BILE DUCT STENT WITH A DOUBLE-BALLOON ENDOSCOPE WAS BEING PLACED TO TREAT THE PATIENT AFTER R-Y RECONSTRUCTION, THE CANNULATION COULD NOT BE PERFORMED. THE PHYSICIAN SWITCHED TO RENDEZVOUS METHOD FROM PTCD ROUTE. REPORTEDLY, THE DISTAL TIP OF THE JAGWIRE DETACHED. THE PROCEDURE TIME WAS OVER 150 MINUTES AND CANNULATION WAS NOT SUCCESSFULLY COMPLETED THEREFORE THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10822362 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE JAGWIRE WAS INSERTED AND A CANNULA WAS INSERTED OVER THE GUIDEWIRE THE DISTAL PART OF PANCREATIC DUCT WAS PERFORATED. IT WAS REPORTED THAT THE JAGWIRE REACHED THE TARGET SITE HOWEVER, THE CANNULA DID NOT. ACCORDING PHYSICIAN'S ASSESSMENT, THERE WAS NO DEVICE MALFUNCTION, HOWEVER, THE GUIDEWIRE CONTRIBUTED TO THE PERFORATION OF THE PANCREATIC DUCT. THE STONE REMOVAL WAS COMPLETED AS PLANNED. REPORTEDLY, A PANCREATIC STENT WAS PLACED AND CONSERVATIVE TREATMENT WAS DONE. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: Perforation

  MAUDE report 10055973 ↗
• MalfunctionFeb 5, 2019Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED IN THE COLON SD PART DURING A COLON STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. THIS DEVICE WAS USED FOR A REPLACEMENT OF AN ILEUS TUBE BEING PLACED FOR A PATIENT WITH MULTIPLE SCLEROSIS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JAGWIRE GUIDEWIRE WAS INSERTED INTO THE LUMEN OF THE ILEUS TUBE. WHILE THE GUIDEWIRE WAS IN PLACE, THE ILEUS TUBE WAS REMOVED. THE ENDOSCOPE WAS BACKLOADED OVER THE GUIDEWIRE AND ADVANCED TO THE TARGET AREA.  AN ATTEMPT WAS MADE TO BACKLOAD THE  WALLFLEX COLONIC STENT OVER THE GUIDEWIRE AND INTO THE SCOPE HOWEVER, THE JACKET ACCORDION AND WAS UNABLE TO BE REMOVED.  UPON REMOVAL OF BOTH DEVICES IT WAS NOTED THE PTFE COATING PEELED. A NEW JAGWIRE GUIDEWIRE AND WALLFLEX COLONIC STENT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; BROKEN COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8307487 ↗
• MalfunctionMar 1, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE¿ GUIDEWIRE WAS USED IN THE COMMON BILE DUCT DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AS THEY WERE CAPTURING THE STONES IN THE LEFT INTRAHEPATIC BILE DUCT, CANNULATION WAS PERFORMED AND WAS PASSED THROUGH THE STONES. CONTRAST IMAGING WAS THEN PERFORMED. AFTER THAT, AS THEY TRIED TO EXCHANGE IT BUT THE GUIDEWIRE COULD NOT BE MOVED AND WAS STUCK IN THE STONES. THEY TRIED TO MOVED IT SEVERAL TIMES BUT MET WITH RESISTANCE THE CORE WIRE WAS BROKEN AS WELL AS THE HYDROPHILIC TIP DETACHED AND REMAINED ON THE DISTAL PART OF THE STONES. THEY REPLACED IT WITH A DIFFERENT GUIDEWIRE AND ATTEMPTED TO RETRIEVE THE STONES USING A RETRIEVAL BALLOON, HOWEVER THE RETRIEVAL BALLOON WOULD NOT PASS THROUGH THE STONES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307776 ↗