Hydra Jagwire M00556060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729747116), received between Jun 27, 2019 and Sep 15, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Entrapment of Device; Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778599 ↗
• InjuryMar 11, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA JAGWIRE WAS USED DURING A RENDEVOUZ ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE HYDRA JAGWIRE LOOKED STRANGE UNDER RADIOLOGIC PROCEDURE. WHEN THEY REMOVED IT, THEY REALIZED THAT THE CURVATURE WAS MISSING. IT WAS ALSO REPORTED THAT THE HYDRA JAGWIRE CAME WITH ONLY ONE FLEXIBLE TIP. THE PHYSICIAN NOTICED IT UNDER THE RADIOLOGIC VISION AND THE PATIENT WAS PERFORATED. THE PROCEDURE WAS COMPLETED WITH A SECOND HYDRA JAGWIRE. NO FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Perforation

  MAUDE report 18881836 ↗
• MalfunctionJun 27, 2019Break; Peeled/Delaminated; Difficult to Remove; Break; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA JAGWIRE GUIDEWIRE WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE GUIDEWIRE TO ACCESS THE BILE DUCT AND IT WAS NOTICED THAT THE COATING PTFE PEELED INSIDE THE COMMON BILE DUCT (CBD) AND WAS HAVING DIFFICULTY REMOVING THE GUIDEWIRE. THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY (IR) TO RETRIEVE THE DETACHED PIECE; HOWEVER, UPON REMOVAL, THE CORE WIRE BROKE AND THE DETACHED PIECE REMAINED IN THE CBD. THE PROCEDURE WAS COMPLETED WITH A SECOND HYDRA JAGWIRE. 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 8741461 ↗