Hydra Jagwire M00556000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729747055), received between Nov 12, 2024 and Jun 3, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO A HYDRATOME RX 44, HYDRA JAGWIRE, AND ADVANIX RX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44, HYDRA JAGWIRE, AND ADVANIX RX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUSTOMER EXPERIENCED DIFFICULTY DEPLOYING TWO PLASTIC BILIARY STENTS OVER A HYDRAWIRE. THE GUIDEWIRE COULD NOT BE ADVANCED BEYOND THE STENT/SUTURE/PUSHER ASSEMBLY. THE CUSTOMER RETRACTED THE BLACK GUIDE CATHETER TO REPOSITION IT PRIOR TO ADVANCING IT OVER THE WIRE AND ATTEMPTED DEPLOYMENT MULTIPLE TIMES WITHOUT SUCCESS. FORCE WAS SUBSEQUENTLY APPLIED, RESULTING IN SUTURE BREAKAGE AND STENT MISDEPLOYMENT. THE PROCEDURE WAS ABORTED AND NO STENT WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386453 ↗
• 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 # 3005099803-2024-05666, 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: Cholangitis; Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation

  MAUDE report 20670722 ↗