Expect M00550010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729790044), received between Mar 7, 2017 and Apr 20, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT¿ NEEDLE DEVICE WAS USED IN THE TAIL OF PANCREAS DURING AN ENDOSCOPIC ULTRASOUND FINE NEEDLE ASPIRATION (EUS FNA) PROCEDURE PERFORMED ON (B)(6) 2014 AS PART OF THE E7084 EUS FNA CYSTIC LESIONS CLINICAL STUDY. THE PATIENT HAD A HISTORY OF DIABETES. THE PATIENT¿S PANCREATIC CYSTIC LESION (PCL) WAS LOCATED IN THE TAIL OF THE PANCREAS AND WAS NOT SYMPTOMATIC. THE PCL WAS UNILOCULAR AND HAD A MAXIMAL DIAMETER OF 15MM AND A PERPENDICULAR MEASUREMENT OF 12MM. THE PCL WAS CONNECTED TO THE PANCREATIC DUCT. THERE WERE NO SOLID COMPONENTS, NO PRESENCE OF VISIBLE MUCIN, AND NO DISTINCT PCL WALL. THE MAXIMAL PANCREATIC DUCT DIAMETER SIZE WAS 23MM AND A MURAL NODULE WAS NOT PRESENT. ON (B)(6) 2014, THE PATIENT UNDERWENT EUS FNA. PROPHYLACTIC ANTIBIOTICS WERE GIVEN AND THE ROUTE OF ACCESS OF THE ECHOENDOSCOPE WAS GASTRIC. DURING THE PROCEDURE, THE PCL COULD BE REACHED AND PENETRATED. ONE PASS WAS ATTEMPTED AND WAS SUCCESSFUL, AND NO SALVAGE PROCEDURE WAS REQUIRED. THE TOTAL VOLUME OF ASPIRATE WAS 2ML. THE ASPIRATE¿S VISCOSITY WAS LIKE WATER, THE CLARITY WAS CLEAR, THE COLOR WAS TRANSPARENT. PER THE EUS FNA, THE DISEASE WAS DETERMINED

  Patient problems: Inflammation

  MAUDE report 7446925 ↗
• MalfunctionMar 7, 2017Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT NEEDLE WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC ULTRASOUND WITH FINE NEEDLE ASPIRATION (EUS FNA) ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE HAD PUNCTURED THROUGH THE SHEATH. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE CASE. 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 6385090 ↗