N/AN/A SSL1015ME.Recalls & reported problems
Medical Components, Inc. · 10F X 15CM SILICONE SINGLE10F X LUMEN CATHETER SETLUMEN CATHETER W/STYLET & W/DILATOR · Class 2 · Implant
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 00884908049497), received between Nov 6, 2019 and Nov 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2019Leak/Splash; Leak/Splash
CATHETER WAS PERFORATED. AT THE BEGINNING OF THE DIALYSIS SESSION THE NURSE NOTED AIR IN THE LINE CAUSING DIALYSIS TO STOP IMMEDIATELY. A NEW CATHETER WAS INSERTED. THE CATHETER WAS CLAMPED AFTER REMOVING THE GUIDWIRE AND WAS CONNECTED TO A "Y" CONNECTOR BECAUSE IT WAS A SINGLE LUMEN CATHETER. AIR WAS NOTED IN THE EXTENSION. THE PERFORATION WAS NOTED BETWEEN THE EXTENSION AND THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9284390 ↗
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- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
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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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