N/AN/A SSL1220ME.Recalls & reported problems
Medical Components, Inc. · 12F X 20CM SILICONE SINGLE12F X LUMEN CATHETER SETLUMEN CATHETER W/STYLET & W/DILATOR · Class 2 · Implant
- 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 00884908049541), received between Jun 16, 2025 and Jun 16, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2025Leak/Splash; Leak/Splash
DURING THE DISCONNECTION OF THE DIALYSIS, BLOOD WAS COLLECTED FROM CATHETER WITH THE LUER LOCK-COMPATIBLE CARRIED OUT. BUBBLING WAS OBSERVED IN THE BRANCHS AND AIR INTAKE WITH BLOOD BEADING THE FLEXIBLE OUTER WALL OF THE FEMORAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210372 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.