Expect Slimline SL M00555500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729848141), received between Mar 2, 2017 and Feb 3, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Use of Device Problem; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE NEEDLE WAS USED DURING A PROCEDURE TO INSERT A COIL TO CONTROL A BLEEDING GASTRIC VARIX ON (B)(6) 2025. DURING PROCEDURE, THE EXPECT SLIMLINE NEEDLE WAS INSERTED IN THE VARIX, THE AREA WAS VERY MOBILE DUE TO RESPIRATIONS AND HICCUPPING. THE STYLET WAS REMOVED FROM THE NEEDLE; A COIL WAS PLACED IN THE NEEDLE AND THE STYLET WAS ATTEMPTED TO BE ADVANCED TO PUSH THE COIL INTO THE VARIX AND STOP THE BLEEDING. THE COIL WOULD ONLY ADVANCE TO ABOUT THE HALFWAY POINT AND BECAME STUCK THE SCOPE WAS ATTEMPTED TO BE REPOSITIONED BUT WAS UNSUCCESSFUL. A GASTROSCOPE WAS PUT UP TO GLUE THE VARIX UNDER ENDOSCOPIC VIEW, BUT THE VARIX STARTED BLEEDING AND THE PATIENT BECAME UNSTABLE. A CODE 66 WAS CALLED AND RESUSCITATION WAS INITIATED; THE PATIENT WAS INTUBATED AFTER THE SCOPE WAS REMOVED. THE PATIENT WAS ADMITTED TO ICU WHERE THE VARIX WAS INJECTED WITH GLUE TO STOP THE BLEEDING. ANOTHER EXPECT SLIMLINE NEEDLE WAS OPENED OUTSIDE THE PATIENT AND A COIL WAS ATTEMPTED BE ADVANCED THROUGH THE NEEDLE AND IT ALSO BECAME STUCK. ACCORDING TO THE INDICATION FOR USE SET BY THE MANUFACTURER, THE DEVICE IS INTENDED TO BE USED FOR THE DEL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246542 ↗
• MalfunctionOct 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE NEEDLE WAS USED IN THE LIVER DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE NEEDLE SEPARATED FROM THE SHAFT. THE DISTAL TIP DID NOT DETACH INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20421082 ↗
• InjuryOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE (SL) WAS USED DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE NEEDLE DETACHED ITSELF FROM THE HANDLE. THE NEEDLE WAS SUCCESSFULLY REMOVED WITHOUT DAMAGING THE SCOPE OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346608 ↗
• MalfunctionApr 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE SL NEEDLE WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE DEVICE. A PHOTO WAS PROVIDED BY THE CUSTOMER SHOWING THAT THE DISTAL END OF THE NEEDLE DETACHED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164157 ↗
• MalfunctionSep 17, 2021Difficult to Advance; Material Deformation; Appropriate Device Problem Term/Code Not Available; Difficult to Advance; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE NEEDLE WAS USED DURING AN ENDOSCOPIC GUIDED BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE NEEDLE COULD NOT ADVANCE THROUGH THE ENDOSCOPE. THE NEEDLE WAS WITHDRAWN AND IT WAS NOTED THAT THE WORKING LENGTH WAS BENT. THE ENDOSCOPE CHANNEL WAS DAMAGED AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487983 ↗
• MalfunctionMar 2, 2017Material Perforation; Material Perforation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT¿ NEEDLE DEVICE WAS USED IN THE PANCREATIC DURING AN ENDOSCOPIC ULTRASOUND FINE NEEDLE ASPIRATION (EUS FNA) PROCEDURE PERFORMED ON UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE COMPLAINANT REPORTED THE NEEDLE WAS UNABLE TO ADVANCE AND ADJUST THE HANDLE. 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 STABLE. THE INVESTIGATION FOUND THAT THE NEEDLE PUNCTURED THROUGH THE SHEATH AND THE DISTAL TIP WAS BENT, THIS IS NOW DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372818 ↗