Jagwire M00556600Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729747246), received between Sep 12, 2017 and Aug 20, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Device-Device Incompatibility; Material Deformation

  Patient problems: Foreign Body In Patient

  MAUDE report 50351124 ↗
• InjuryMay 31, 2023Break; 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 JAGWIRE WAS USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT WHEN THE JAGWIRE WAS PULLED THROUGH, THE COREWIRE BROKE AND REMAINED INSIDE THE PANCREATIC DUCT. REPORTEDLY, THE PATIENT STAYED LONGER AT THE HOSPITAL FOR FURTHER OBSERVATION AND WAS SENT FOR IMAGING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029827 ↗
• MalfunctionFeb 2, 2023Material Separation

  DURING ATTEMPTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), DOCTOR WAS USING THE ECHOTIP ULTRA 19-A WITH THE JAGWIRE STRAIGHT TIP 0.035 IN AND A PIECE OF THE HYDROPHILIC COATING WAS CUT OFF. UNABLE TO RETRIEVE THE COATING.

  Patient problems: Insufficient Information

  MAUDE report 16283340 ↗
• MalfunctionApr 28, 2022Peeled/Delaminated; Peeled/Delaminated

  NOTES: THIS REPORT PERTAINS TO TWO SPYSCOPE DS II, ONE SPY DS CONTROLLER AND TWO JAGWIRES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYSCOPE DS II, ONE SPY DS CONTROLLER AND TWO JAGWIRE GUIDEWIRES WERE USED IN THE BILIARY TRACT DURING A CHOLANGIOSCOPIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN PUT A SPYSCOPE AND A JAGWIRE INTO THE BILIARY TRACT. DURING THE EXCHANGE, THE JACKET ON THE GUIDEWIRE STRIPPED AWAY FROM THE INNER SHAFT. THE SPYSCOPE COULD NOT BE BACK LOADED OVER THE GUIDEWIRE. A NEW JAGWIRE WAS USED TO CANNULATE AGAIN. WHEN CANNULATION WAS DONE AND THE PHYSICIAN TRIED TO EXCHANGE THE WIRE, THE WIRE STRIPPED AGAIN. THE PHYSICIAN TOOK OUT THE SPYSCOPE WITH THE GUIDEWIRE AND DECIDED NOT TO PROCEED WITH THE USE OF A GUIDEWIRE. THEN THE SPYSCOPE WAS REINSERTED AND DURING WATER INJECTION, THE SPYSCOPE STOPPED WORKING. THE SPYSCOPE WAS REPLACED WITH A SECOND SPYSCOPE BUT THE SAME PROBLEM OCCURRED. IT IS UNKNOWN IF THE PHYSICIAN WAS BLASTING STONES OR INJECTING WATER WHEN THE SECOND SPYSCOPE STOP WORKING. THE PROCEDURE WAS CHANGED TO A REGULAR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14244778 ↗
• MalfunctionApr 28, 2022Peeled/Delaminated; Peeled/Delaminated

  NOTES: THIS REPORT PERTAINS TO TWO SPYSCOPE DS II, ONE SPY DS CONTROLLER AND TWO JAGWIRES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYSCOPE DS II, ONE SPY DS CONTROLLER AND TWO JAGWIRE GUIDEWIRES WERE USED IN THE BILIARY TRACT DURING A CHOLANGIOSCOPIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN PUT A SPYSCOPE AND A JAGWIRE INTO THE BILIARY TRACT. DURING THE EXCHANGE, THE JACKET ON THE GUIDEWIRE STRIPPED AWAY FROM THE INNER SHAFT. THE SPYSCOPE COULD NOT BE BACK LOADED OVER THE GUIDEWIRE. A NEW JAGWIRE WAS USED TO CANNULATE AGAIN. WHEN CANNULATION WAS DONE AND THE PHYSICIAN TRIED TO EXCHANGE THE WIRE, THE WIRE STRIPPED AGAIN. THE PHYSICIAN TOOK OUT THE SPYSCOPE WITH THE GUIDEWIRE AND DECIDED NOT TO PROCEED WITH THE USE OF A GUIDEWIRE. THEN THE SPYSCOPE WAS REINSERTED AND DURING WATER INJECTION, THE SPYSCOPE STOPPED WORKING. THE SPYSCOPE WAS REPLACED WITH A SECOND SPYSCOPE BUT THE SAME PROBLEM OCCURRED. IT IS UNKNOWN IF THE PHYSICIAN WAS BLASTING STONES OR INJECTING WATER WHEN THE SECOND SPYSCOPE STOP WORKING. THE PROCEDURE WAS CHANGED TO A REGULAR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14244711 ↗
• InjuryDec 4, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE FIRST ERCP PROCEDURE WAS TO REMOVE STONES AND A PLASTIC STENT OUT OF THE COMMON BILE DUCT. IN ADDITION, CONCREMENTS WERE ALSO REMOVED WHICH HAD BEEN DISCOVERED BY THE APPLICATION OF CONTRAST AGENTS IN THE DISTAL PART OF THE COMMON BILE DUCT. THE CONCREMENTS WERE REMOVED USING A BASKET AND A BALLOON (MANUFACTURERS UNKNOWN). THEY USED CONTRAST MEDIUM IN THE FIRST ERCP BUT WITH CATHETER, PANCREAS HEAD AND CORPUS ARE NOT SELECTIVELY DISPLAYED WITHOUT LATERAL BRANCHES. A COMPLETE VISUALIZATION OF THE PANCREATIC DUCT WAS NOT INTENDED. THERE WERE NO REPORTED ISSUES WITH THE JAGWIRE. THE PATIENT WAS STABLE POST-PROCEDURE. A DAY LATER THE PATIENT'S CHOLESTASIS VALUES INCREASED. THEREFORE, A SECOND ERCP PROCEDURE WAS PERFORMED, DUE TO POST ERCP PANCREATITIS. CONTRAST MEDIUM WAS USED BUT A VISUALIZATION OF THE PANCREATIC DUCT WAS OMITTED. A 2CM PIECE OF THE JAGWIRE COATING WAS FOUND INSIDE THE BILE DUCT, AND WAS SUCCESSFULLY RETRIEVED USING A BALLOON CATHETER (MANUFACTURER UNKNOWN). IN THE

  Patient problems: Inflammation

  MAUDE report 8131389 ↗
• InjurySep 12, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE¿ WAS USED DURING AN ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE PERFORMED VIA LEFT ARM BRACHIAL ACCESS ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JAGWIRE WAS ADVANCED INTO THE ABDOMINAL AORTA VIA FEMORAL ACCESS SHEATH. THE PHYSICIAN ADVANCED A SNARE INTO THE BRACHIAL ACCESS SHEATH AND SNARED THE JAGWIRE TO PULL THE WIRE OUT OF THE BRACHIAL SHEATH. REPORTEDLY, THE HYDROPHILIC TIP OF THE JAGWIRE CAME OFF WHICH WAS RECOVERED INSIDE THE HUB OF THE BRACHIAL SHEATH. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGWIRE. ADDITIONALLY, THE DIRECTIONS FOR USE INDICATE "THE JAGWIRE HIGH PERFORMANCE GUIDEWIRE IS INDICATED FOR USE IN SELECTIVE CANNULATION OF THE BILIARY DUCTS INCLUDING, BUT NOT LIMITED TO THE COMMON BILE, CYSTIC, RIGHT AND LEFT HEPATIC DUCTS. THE JAGWIRE HIGH PERFORMANCE GUIDEWIRE IS DESIGNED TO BE USED DURING ENDOSCOPIC BILIARY PROCEDURES FOR CATHETER INTRODUCTION AND EXCHANGES. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6859669 ↗