Jagwire M00556560Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729858539), received between Dec 7, 2017 and Feb 23, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT JAGWIRE WAS INSPECTED AT THE DISTRIBUTION FACILITY ON (B)(6) 2026. DURING THE INSPECTION, IT WAS REPORTED THAT THE STERILE SEAL OF THE DEVICE POUCH PEELED OFF. THE REPORTED EVENT MAY SUGGEST THAT THE STERILITY OF THE DEVICE HAS BEEN COMPROMISED. THERE WERE NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24423723 ↗
• MalfunctionJan 4, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; 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 DURING A PANCREATIC STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE 3-5 MM TIP DETACHED WHILE SEEKING INSIDE THE PANCREATIC DUCT WITH A CANNULA AND WIRE, THE REMAINS WERE FOUND IN FLUOROSCOPIC IMAGES AND WAS SAFELY REMOVED FROM THE PANCREATIC DUCT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096956 ↗
• MalfunctionJun 29, 2022Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED IN THE BILE DUCT DURING A COMMON BILE DUCT STONE REMOVAL PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS CONFIRMED VIA ENDOSCOPY THAT A FEW MILLIMETERS OF THE COREWIRE TIP BROKE WHILE MANIPULATING THE GUIDEWIRE. THE TIP PART DETACHED IN DUODENUM AND REMAINED IN THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH AN ENDOSELECTOR GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14856246 ↗
• MalfunctionJun 19, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE¿ GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED CORRECTLY IN THE COMMON BILE DUCT. WHEN THE PHYSICIAN TRIED TO WITHDRAW THE DELIVERY SYSTEM , IT BECAME STUCK. THE STENT DID NOT MOVE WHEN THE DELIVERY SYSTEM WAS PULLED OUT. THE PHYSICIAN ENDED UP PULLING THE WIRE AND THE DELIVERY SYSTEM; HOWEVER, THE DELIVERY SYSTEM SNAPPED, LEAVING A PORTION OF THE WIRE IN THE DUCT. THEY WERE ABLE TO RETRIEVE A PIECE OF THE DELIVERY SYSTEM THAT BROKE OFF BY USING A FORCEPS BUT THE DISTAL OR FLOPPY TIP OF THE JAGWIRE REMAINED IN THE DUCT. REPORTED, THE STRICTURE WAS VERY TIGHT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE BY PLACING A 8X80 WALLFLEX BILIARY UNCOVERED STENT TO ENSURE PROPER DRAINAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. INVESTIGATION RESULTS REVEALED ON MAY 28, 2018 THAT THE CORE WIRE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7615913 ↗
• MalfunctionDec 20, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS UNPACKED. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THERE WERE A LOT OF DUST SEEN INSIDE THE OUTER SHIPPING BOX, NOT INSIDE THE POUCH. THERE WAS NO PROCEDURE INVOLVED AND THE DEVICE WAS NOT USED IN THE PATIENT. INVESTIGATION RESULTS REVEALED ON (B)(6) 2017 THAT THERE WAS A FOREIGN MATERIAL INSIDE ONE OF THE POUCHES.

  Patient problems: No Patient Involvement

  MAUDE report 7135479 ↗
• MalfunctionDec 7, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AS THE GUIDEWIRE WAS PULLED OUT, THE CORE WIRE WAS BROKEN AT THE LAST 3-4CM FROM THE TIP. THERE WAS A PART OF THE GUIDEWIRE THAT LEFT IN THE DUCT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7096615 ↗