Jagwire M00557640Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729747529), received between Jul 15, 2026 and Jul 15, 2026 — classified as 1 injury.

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

• 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 ↗