Hydra Jagwire M00556040Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729747093), received between Jun 28, 2017 and Jan 13, 2026 — classified as 3 injuries, 4 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. 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.

• InjuryJan 13, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA JAGWIRE WAS USED IN THE STOMACH AND DUODENUM DURING A PANCREATOGRAPHY AND PANCREATOGASTROSTOMY PROCEDURE TO TREAT CANCER PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE COATING ON THE GUIDE HAD COME OFF, AND A PART OF THE GUIDE HAD BROKEN OFF. IT WAS THEN REPORTED THAT THE CORE WIRE OF THE DEVICE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 FULLY RECOVERED. ADDITIONAL INFORMATION RECEIVED JANUARY 20, 2026. IT WAS REPORTED THAT A SNARE WAS USED TO RETRIEVE THE BROKEN CORE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064112 ↗
• MalfunctionJun 5, 2025Peeled/Delaminated; Difficult to Remove; Material Deformation; Peeled/Delaminated; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA JAGWIRE WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC ULTRASOUND (EUS) RENDEZVOUS PROCEDURE TO TREAT A BILE DUCT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE COATING OF THE GUIDEWIRE APPEARED TO HAVE A ROUGH SURFACE, MAKING IT DIFFICULT TO REMOVE AND CAUSING THE COATING TO PEEL/STRIP FROM THE WIRE. THE WIRE BECAME STUCK IN THE ACCOMPANYING FNB EUS NEEDLE AND COULD NOT BE REMOVED. THE NEEDLE WAS FORCEFULLY EXTRACTED ONLY AFTER THE SCOPE WAS REMOVED FROM THE PATIENT WITH BOTH THE NEEDLE AND WIRE STILL CONNECTED. AS A RESULT, THE PROCEDURE WAS CANCELED, AND THE PATIENT WAS SCHEDULED FOR PTC (PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY) THE NEXT DAY. TWO PHOTOS OF THE DEVICE WERE PROVIDED, AND ONE CLEARLY SHOWS THE GUIDEWIRE COATING IS ROUGH AND DISTORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155773 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES MENTIONED IN THE LITERATURE ARTICLE. REFER TO MANUFACTURER REPORTS # 3005099803-2024-05668, 3005099803-2024-05669, 3005099803-2024-05804, 3005099803-2024-05805 AND 3005099803-2024-05806 FOR THE ASSOCIATED DEVICE INFORMATION. BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING JAGWIRE GUIDEWIRES, AUTOTOME RX SPHINCTEROTOMES, PULL TYPE SPHINCTEROTOMES, MICROKNIFE NEEDLE KNIFE PAPILLOTOMES, AND RX LOCKING DEVICES THROUGH THE ARTICLE, COMPARISON OF PHYSICIAN-CONTROLLED MANEUVER AND ASSISTANT-CONTROLLED MANEUVER DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, BY MIN JE SUNG, ET AL. PER THE ARTICLE, BETWEEN JANUARY 2015 AND DECEMBER 2016, PATIENTS UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN WHICH PHYSICIAN-CONTROLLED WIRE-GUIDED CANNULATION (PCWGC) AND/OR ASSISTANT-CONTROLLED WIRE-GUIDED CANNULATION (ACWGC) CANNULATION TECHNIQUES WERE USED. IN CASES WHERE PCWGC WAS UTILIZED, THE FOLLOWING OCCURRED: PANCREATITIS, BLEEDING, PERFORATION, CHOLANGITIS. IN CASES WHERE ACWGC WAS UTILIZED, THE FOLLOWING OCCURRED: PANCREATITIS, BLEEDING, PERFORATION. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation

  MAUDE report 20670687 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA-JAGWIRE WAS USED DURING A PERCUTANEOUS CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2021. DURING PROCEDURE, THERE WERE NO REPORTED MALFUNCTIONS WITH THE DEVICE AND THE PROCEDURE WAS COMPLETED WITH THIS GUIDEWIRE. FOLLOWING THE CASE WHEN II IMAGES WERE REVIEWED IT WAS NOTED THERE WAS A PERFORATION OF CYSTIC DUCT STUMP. THE PHYSICIAN ADVISED NO FURTHER TREATMENT IS REQUIRED AT THIS TIME. IT WAS REPORTED THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Perforation

  MAUDE report 12508663 ↗
• MalfunctionApr 6, 2021Break; Difficult to Advance; Material Integrity Problem; Break; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA JAGWIRE GUIDEWIRE WAS USED IN THE COMMON BILE DUCT DURING AN ERCP PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS DIFFICULT TO ADVANCE THE AUTOTOME 44 OVER THE HYDRA JAGWIRE. THE PROCEDURE COMPLETED WITH ANOTHER HYDRA JAGWIRE AND THE SAME AUTOTOME 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE BREAK. PLEASE REFER TO BLOCK H10 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624218 ↗
• MalfunctionOct 30, 2019Break; Entrapment of Device; Peeled/Delaminated; Break; Entrapment of Device; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA JAGWIRE GUIDEWIRE WAS USED DURING AN EUS-DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NEEDED TO PASS A NEEDLE THROUGH THE REMNANT STOMACH TO FILL WITH SALINE AND CONTRAST AS WELL AS PLACE A BOSTON SCIENTIFIC STENT. A HYDRA JAGWIRE WIRE WAS PLACED THROUGH THE EXPECT NEEDLE, THE NEEDLE TIP PEELED THE HYDROPHILIC COATING ON THE GUIDEWIRE. THE HYDRA JAGWIRE PTFE JACKET COATING PEELED AND THE COATING BECAME STUCK IN THE DISTAL END OF THE NEEDLE. REPORTEDLY, THE COREWIRE TIP BROKE OFF INSIDE NEEDLE. A NEW EXPECT NEEDLE AND HYDRA JAGWIRE WERE USED TO COMPLETE THE PROCEDURE. 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 9256883 ↗
• MalfunctionJun 28, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA JAGWIRE¿ GUIDEWIRE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE COATING OF THE GUIDEWIRE TIP CAME OFF. THE PROCEDURE WAS COMPLETED WITH A NEW HYDRA JAGWIRE¿ GUIDEWIRE. 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 NO PATIENT INJURY. INVESTIGATION RESULTS REVEALED ON JUNE 9, 2017 THAT THE CORE WIRE IS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6672712 ↗