JagwireRecalls & reported problems across all models

We found 11 models of Jagwire by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between Jan 13, 2017 and Sep 11, 2026 — classified as 1 death, 15 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Break” (32 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. 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

Most reported Jagwire problems

Jagwire models

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

• Jagwire M00556580

  Endoscopic guidewire, gastroenterology-urology
  1 death49 reports
• Jagwire M00556600

  Endoscopic guidewire, gastroenterology-urology
  7 reports
• Jagwire M00556610

  Endoscopic guidewire, gastroenterology-urology
  6 reports
• Jagwire M00556560

  Endoscopic guidewire, gastroenterology-urology
  6 reports
• Jagwire M00556590

  Endoscopic guidewire, gastroenterology-urology
  5 reports
• Jagwire M00556530

  Endoscopic guidewire, gastroenterology-urology
  3 reports
• Jagwire M00556620

  Endoscopic guidewire, gastroenterology-urology
  1 report
• Jagwire M00556650

  Endoscopic guidewire, gastroenterology-urology
  1 report
• Jagwire M00556660

  Endoscopic guidewire, gastroenterology-urology
  1 report
• Jagwire M00556860

  Endoscopic guidewire, gastroenterology-urology
  1 report
• Jagwire M00557640

  Endoscopic guidewire, gastroenterology-urology
  1 report

Recent Jagwire adverse event reports

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

• MalfunctionSep 11, 2026Difficult to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744400 ↗
• InjuryAug 20, 2026Device-Device Incompatibility; Material Deformation

  Patient problems: Foreign Body In Patient

  MAUDE report 50351124 ↗
• MalfunctionJul 17, 2026Difficult to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25851565 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CYSTOGASTROSTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A BLUE TUBE WAS RETRIEVED FROM THE PATIENT'S STOMACH. FURTHER COMPARISON TO DEVICE PACKAGING DETERMINED THAT THE BLUE TUBE WAS FROM THE JAGWIRE USED DURING THE INITIAL PROCEDURE ON 01 JUN 2026. A PHOTO OF A SIMILAR DEVICE WAS PROVIDED AND INDICATED THE BLUE TUBE FROM THE DEVICE THAT SHOULD BE REMOVED AND DISCARDED BEFORE USE. IT WAS REPORTED THAT THE BLUE TUBE WAS THE ONE THAT FELL INSIDE THE PATIENT; HOWEVER, PER THE INSTRUCTIONS FOR USE (IFU), TO REMOVE THE GUIDEWIRE FROM THE HOOP, FIRST REMOVE AND DISCARD THE SMALL BLUE TUBE FROM THE INNER DIAMETER OF THE CLEAR HOOP. ADVANCE WIRE UNTIL THE WIRE IS EXPOSED OUT OF THE OUTER DIAMETER OF THE HOOP. A FOLLOW-UP CT SCAN IS PLANNED IN 4-6 WEEKS TO REASSESS THE CONDITION PRIOR TO STENT REMOVAL. IT WAS REPORTED THAT THE PATIENT'S CURRENT CONDITION IS CLINICALLY WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829204 ↗
• MalfunctionJul 9, 2026Detachment 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 COLON DURING A COLON STENT PLACEMENT PROCEDURE TO TREAT COLORECTAL CANCER PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DISTAL TIP WAS SEPARATED AND REMAINED IN THE BODY. IT WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS DISCONTINUED AND EVENTUALLY CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25771548 ↗
• MalfunctionApr 1, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS RECEIVED BY THE CUSTOMER ON (B)(6) 2026. IT WAS REPORTED THAT A PERFORATION WAS REPORTED ON THE PRODUCT PACKAGING, CAUSING THE CONTENTS TO BECOME VISIBLE. THE DEVICE WAS NOT USED IN A PROCEDURE. THE REPORTED EVENT MAY SUGGEST THAT THE STERILE BARRIER WAS COMPROMISED DUE TO THE DAMAGED PACKAGING. 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 24760559 ↗
• MalfunctionMar 18, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS ATTEMPTED TO BE USED IN COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, TIP OF WIRE BROKE OFF. 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 WAS REPORTED TO BE FULLY RECOVERED. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CORE WIRE DETACHED/SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628677 ↗
• 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 ↗
• MalfunctionFeb 3, 2026Nonstandard Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE JAGWIRE WAS REPORTED AS DEFECTIVE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS REPORTED THAT THE PATIENT HOSPITALIZATION WAS PROLONGED. 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 24248822 ↗
• MalfunctionJan 12, 2026Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR JAGWIRES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ADVANCING THE GUIDEWIRE INTO THE COMMON BILE DUCT, PEELING OCCURRED ON THE BLACK PART OF THE HYDROPHILIC TIP. THE SAME PROBLEM OCCURRED WITH THE OTHER THREE JAGWIRES. DUE TO THIS PROBLEM, THE PROCEDURE HAD TO BE TERMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049823 ↗
• MalfunctionJan 12, 2026Peeled/Delaminated

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR JAGWIRES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ADVANCING THE GUIDEWIRE INTO THE COMMON BILE DUCT, PEELING OCCURRED ON THE BLACK PART OF THE HYDROPHILIC TIP. THE SAME PROBLEM OCCURRED WITH THE OTHER THREE JAGWIRES. DUE TO THIS PROBLEM, THE PROCEDURE HAD TO BE TERMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049647 ↗
• MalfunctionJan 12, 2026Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR JAGWIRES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ADVANCING THE GUIDEWIRE INTO THE COMMON BILE DUCT, PEELING OCCURRED ON THE BLACK PART OF THE HYDROPHILIC TIP. THE SAME PROBLEM OCCURRED WITH THE OTHER THREE JAGWIRES. DUE TO THIS PROBLEM, THE PROCEDURE HAD TO BE TERMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049627 ↗
• MalfunctionJan 12, 2026Peeled/Delaminated

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR JAGWIRES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ADVANCING THE GUIDEWIRE INTO THE COMMON BILE DUCT, PEELING OCCURRED ON THE BLACK PART OF THE HYDROPHILIC TIP. THE SAME PROBLEM OCCURRED WITH THE OTHER THREE JAGWIRES. DUE TO THIS PROBLEM, THE PROCEDURE HAD TO BE TERMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049515 ↗
• 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 ↗
• InjuryJun 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDEWIRE EXPERIENCED AN UNANTICIPATED DISTAL FRACTURE INTO SEVERAL SEGMENTS, AS IT WAS EMERGING FROM THE TIP OF THE SCOPE AND PRIOR TO ENTERING THE COMMON BILE DUCT. ALSO, IT WAS NOTED THAT THE DISTAL TIP DETACHED. IT WAS REPORTED THAT THE GUIDEWIRE WAS RETRIEVED IN TWO STAGES. FIRST AS AN INTACT UNIT FOLLOWED BY REMOVAL OF THE FRACTURED SEGMENTS BY BIOPSY GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346865 ↗

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