Expect Slimline SLRecalls & reported problems across all models
Boston Scientific Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 4 models of Expect Slimline SL by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Dec 3, 2015 and Mar 5, 2026 — classified as 6 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Expect Slimline SL problems
Device problems
- Detachment of Device or Device Component9
- Adverse Event Without Identified Device or Use Problem3
- Difficult to Advance2
- Material Integrity Problem2
- Material Puncture/Hole2
- Mechanical Problem2
- Appropriate Device Problem Term/Code Not Available1
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient3
- No Patient Involvement3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
- Inflammation1
Expect Slimline SL models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Expect Slimline SL M00555510Endoscopic ultrasound system, gastroenterology-urology10 reports
- Expect Slimline SL M00555500Endoscopic ultrasound system, gastroenterology-urology6 reports
- Expect Slimline SL M00555530Endoscopic ultrasound system, gastroenterology-urology5 reports
- Expect Slimline SL M00555520Biopsy needle1 report
Recent Expect Slimline SL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Material Puncture/Hole
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE NEEDLE WAS TO BE USED IN THE LIVER DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE WAS DIFFICULT TO USE. THE BEVEL DID NOT APPEAR SUITABLE. WHEN THE GUIDE WAS INSERTED, IT COULD CUT THE THREAD. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT'S CURRENT CONDITION AFTER THE PROCEDURE WAS UNKNOWN. BOSTON SCIENTIFIC CORPORATION HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24516987 ↗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 ↗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 ↗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 ↗MalfunctionMar 13, 2024Detachment 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 SLIMLINE NEEDLE WAS USED IN THE LIVER DURING A LIVER BIOPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE INNER SHEATH WAS DETACHED AND REMAINED INSIDE OF THE ENDOSCOPE. 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 18894647 ↗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 ↗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 ↗MalfunctionApr 4, 2022Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE NEEDLE WAS USED IN THE LUNGS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6)2022. DURING THE PROCEDURE, ONE LYMPH NODE WAS PUNCTURED SUCCESSFULLY WITH THE EXPECT NEEDLE THREE TIMES. HOWEVER, AFTER PUNCTURING THE SECOND LYMPH NODE ON THE SECOND ATTEMPT TIME THE RESISTANCE IN THE HANDLE WAS GONE AND THE NEEDLE IN THE PATIENT WASN'T EXTENDING OR RETRACTING. THE NEEDLE WAS STILL 2 CM OUT, BUT THEY CAREFULLY REMOVED THE NEEDLE TOGETHER WITH THE SCOPE. THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14003928 ↗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 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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