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Hydra Jagwire M00556020Recalls & reported problems

Boston Scientific Corporation · High Performance Guidewire · Class 1

Adverse event reports
1
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729747079), received between Nov 25, 2019 and Nov 25, 2019 — classified as 1 death.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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

Device problems

  • Material Too Rigid or Stiff1

Patient problems

  • Death1
  • Inflammation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathNov 25, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PATIENT GOT SEVERE PANCREATITIS RIGHT AFTER THE PROCEDURE AND DIED. REPORTEDLY, THE GUIDEWIRE WAS TOO STIFF AND CAUSED TRAUMA TO THE PANCREAS. THE CAUSE OF PATIENT'S DEATH WAS UNAVAILABLE. THERE WERE OTHER CO-MORBIDITIES THAT POSSIBLY LED TO THE EVENT; HOWEVER, IT WAS NOT SPECIFIED.

    Patient problems: Death; Inflammation

    MAUDE report 9369201 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.