Expect Slimline SL M00555520Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729848165), received between Dec 29, 2016 and Dec 29, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Packaging Compromised” (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
Device problems
- Device Packaging Compromised1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2016Device Packaging Compromised; Device Packaging Compromised
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT¿ SLIMLINE NEEDLE WAS OPENED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, ONE OF THE EXPECT¿ NEEDLE DEVICES FROM A BOX OF FIVE WAS OPENED AND IT WAS NOTICED THAT THE HANDLE AND NEEDLE WERE STICKING OUTSIDE THE PACKAGING RENDERING THE STERILE BARRIER TO BE COMPROMISED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6214965 ↗
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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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