Expect M00550000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729790051), received between Mar 13, 2018 and Mar 24, 2025 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMar 24, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT 19G EUS NEEDLE WAS USED IN THE STOMACH FUNDUS DURING A PUNCTURE UNDER ENDOSCOPIC ULTRASONOGRAPHY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE TIP CORE WAS FRACTURED DURING THE BIOPSY PUNCTURE AND WAS UNABLE TO PUNCTURE. ANOTHER EXPECT NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21681687 ↗
• InjuryMar 13, 2018Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT ¿ NEEDLE WAS USED IN THE GASTRIC WALL, DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS) PROCEDURE WITH FIDUCIALS PLACEMENT, PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE THE NEEDLE BROKE INSIDE THE PATIENT¿S GASTRIC WALL. IT WAS REMOVED UNEVENTFULLY WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT¿ NEEDLE. 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 7335492 ↗