Expect Slimline SL M00555530Recalls & reported problems
Boston Scientific Corporation · Endoscopic Ultrasound Aspiration Needle · Class 2
All models of Expect Slimline SL (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729848172), received between Jul 3, 2019 and Mar 5, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Material Integrity Problem2
- Detachment of Device or Device Component1
- Material Puncture/Hole1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, 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 ↗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 ↗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 ↗MalfunctionJul 17, 2019Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE NEEDLE WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE NEEDLE WAS BEING ADVANCED DOWN THE SCOPE, THE TIP BROKE OFF. IT IS UNKNOWN HOW THIS PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8798079 ↗MalfunctionJul 3, 2019Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT SLIMLINE NEEDLE WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE THE NEEDLE WAS BEING ADVANCE DOWN THE SCOPE AND THE TIP BROKE OFF. THE COMPLAINANT NOTED THAT THE ANATOMY WAS NOT TORTUROUS. IT IS UNKNOWN HOW THIS PROCEDURE WAS COMPLETED. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8757591 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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