Split Cath® III TRAY 3216-3Recalls & reported problems
Medical Components, Inc. · 16F X 32CM Split Cath® III CATHETER ONLY (CUFF 27CM FROM TIP) · 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 00884908056303), received between Mar 31, 2025 and Mar 31, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
MalfunctionMar 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS RN WAS CLEANING PT'S CATHETER BEFORE TX, BOTH LUMEN TIPS (LUERS) BECAME DETACHED. RN PLACED BOTH TIPS BACK INTO CATHETER, PROCEEDED WITH TX AS NORMAL. THE CATHETER DID STAY INTACT DURING AND AFTER DIALYSIS TX, PER PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21729638 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.