Split Cath® III RMS23602Recalls & reported problems
Medical Components, Inc. · 16F X 28CM Split Cath® III CATHETER SET (CUFF 23CM FROM TIP) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908038583), received between Jul 1, 2019 and Jul 1, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- Chest Pain1
- Dyspnea1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2019Break; Break
DIALYSIS INITIATED USING THE PATIENT'S AVF. THE VENOUS NEEDLE INFILTRATED AND THE DIALYSIS TREATMENT WAS CONVERTED TO USING THE PATIENT'S RIGHT INTERNAL JUGULAR CATHETER, IT WAS NOTED THE ARTERIAL RED CLAMP WAS CRACKED AND UNABLE TO BE CLAMPED. DIALYSIS TREATMENT WAS TERMINATED, CATHETER PORTS FLUSHED AND CAPPED. UPON PATIENT AMBULATING TO SCALE PATIENT BEGAN COUGHING, COMPLAINED OF SHORTNESS OF BREATH AND SEVERE CHEST PAIN. 911 WAS CALLED. PATIENT WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED. PATIENT WAS DISCHARGED FROM THE HOSPITAL 3 DAYS LATER.
Patient problems: Chest Pain; Dyspnea
MAUDE report 8750272 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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