Expect Slimline SL M00555510Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729848158), received between Dec 3, 2015 and Jul 10, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN EXPECT SLIMLINE SL FROM THE 109TH ANNUAL MEETING OF THE JAPAN GASTROENTEROLOGICAL ENDOSCOPY SOCIETY ON-DEMAND VIEWING (WORKSHOP 7) TITLED EUS-HGS IN THE ELDERLY, BY KEIGO OSHIRO, ET AL. PER THE STUDY, THE SAFETY AND CLINICAL OUTCOMES OF EUS-HGS IN ELDERLY PATIENTS WERE EXAMINED RETROSPECTIVELY FROM JANUARY 2017 TO SEPTEMBER 2024. SEVERE COMPLICATIONS MENTIONED INCLUDES SEPTIC SHOCK, PERITONITIS, AND CHOLECYSTITIS. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

  Patient problems: Inflammation; Peritonitis; Septic Shock

  MAUDE report 22470773 ↗
• MalfunctionNov 18, 2022Detachment 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 DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE NEEDLE WAS REMOVED FROM THE PATIENT TO EXPEL SAMPLES AND THE ENTIRE NEEDLE FELL OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT SLIMLINE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 21, 2022: THE PATIENT HAD AN ENDOSCOPIC ULTRASOUND (EUS) PERFORMED IN THE ENDOSCOPY OR SUITE. WHILE DOCTOR WAS OBTAINING A NEEDLE ASPIRATION SPECIMEN DURING THE PROCEDURE, THE NEEDLE FROM BOSTON SCIENTIFIC EXPECT SLIMLINE DEVICE BECAME DISLODGE FROM THE DEPLOYMENT DEVICE. THE NEEDLE WAS RETRIEVED AND ALL PARTS OF THE DEVICE WERE ACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829606 ↗
• InjuryMay 14, 2021Detachment 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 PANCREAS DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION (EUS FNA) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE NEEDLE BROKE OFF AT THE DISTAL END AFTER THE THIRD PASS WHILE SAMPLING A CALCIFIED PANCREATIC MASS. THE NEEDLE TIP (2CM) WAS REMOVED FROM THE PATIENT USING FORCEPS WITH AN OVERTUBE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT SLIMLINE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825006 ↗
• MalfunctionJan 13, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE NEEDLE WAS OPENED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE DEVICE WAS RECEIVED WITH THE SEAL OPENED. ADDITIONALLY, THERE WAS A MARK THAT LOOKED LIKE IT WAS CUT WITH A CUTTER. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

  Patient problems: Insufficient Information; No Patient Involvement

  MAUDE report 11158570 ↗
• MalfunctionJul 9, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE NEEDLE WAS USED DURING AN ECHO ENDO PUNCTURE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN HE DEPLOYED THE DEVICE, THE NEEDLE DID NOT GO STRAIGHT NORMALLY. THE PROCEDURE WAS COMPLETED WITH AN ACQUIRE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT ONE PORTION OF THE NEEDLE WAS RETURNED BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10251661 ↗
• MalfunctionMay 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE 22G EUS NEEDLE WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE WAS REMOVED FROM THE SCOPE, AFTER THE THIRD SAMPLE WAS TAKEN. WHEN THE NEEDLE WAS OUTSIDE OF THE SCOPE, IT WAS NOTICED THAT THE DISTAL TIP OF THE NEEDLE WAS BROKEN. THE NEEDLE WAS REPORTED BROKEN APPROXIMATELY 5 CM FROM THE DISTAL TIP. NOTHING REPORTEDLY DETACHED INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT SLIMLINE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 8, 2024. BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN ARTICLE IN WHICH AN EVENT, PREVIOUSLY ASSESSED, IS REPORTED. THE EVENT IS BEING HIGHLIGHTED ONCE AGAIN THROUGH THE ARTICLE: "NEEDLE FRACTURE, A RARE ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION COMPLICATION AND WHY?." CLINICAL ENDOSCOPY (2021). BY KIM ET AL. PER THE ARTICLE, THE EXPECT NEEDLE WAS USED TO ACQUIRE TISSUE IN THE DUODENUM, NOT THE PANCREAS. DURING THE THIRD PASS, THE ENDOSCOPE SUDDENLY PUSHED BACK INT

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10064998 ↗
• MalfunctionMar 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE NEEDLE WAS OPENED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE 22GA EXPECT SLIMLINE NEEDLE WAS NOTICED TO HAVE HAD A FOREIGN PIECE OF BLUE PLASTIC STUCK IN THE BIOPSY PORT MOUNT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Patient Involvement

  MAUDE report 9801558 ↗
• MalfunctionNov 16, 2017Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT¿ SLIMLINE NEEDLE WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC ULTRASOUND (EUS) ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE WAS STUCK AND WAS UNABLE TO EXTEND OUT OF THE CATHETER. 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 STABLE. THE INVESTIGATION FOUND THAT THE NEEDLE PUNCTURED THE SHEATH, THIS IS NOW DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7037131 ↗
• InjuryFeb 17, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT¿ SLIMLINE NEEDLE WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC ULTRASOUND GUIDED NEEDLE BIOPSY PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE BROKE AND DETACHED INTO THE PATIENT'S DUODENAL WALL. THE DETACHED PIECE WAS SUCCESSFULLY RETRIEVED USING A BIOPSY FORCEPS AND RETRIEVAL NET. THE PROCEDURE WAS STOPPED AND NOT COMPLETED DUE THIS INCIDENT. 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 Consequences Or Impact To Patient

  MAUDE report 6341508 ↗
• InjuryDec 3, 2015Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE NEEDLE DEVICE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE DISTAL TIP OF THE NEEDLE BROKE AND DETACHED INSIDE THE PATIENT. THE DETACHED NEEDLE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT USING 13-MILLIMETER ALLIGATOR FORCEPS, AND THE PROCEDURE WAS ENDED AT THAT TIME. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma; No Known Impact Or Consequence To Patient

  MAUDE report 5266040 ↗