Split Cath® III ASPC18P-XLRecalls & reported problems
Medical Components, Inc. · 10F X 18CM Split Cath® III CATHETER SET (CUFF 15CM FROM TIP) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884908003437), received between Jul 3, 2018 and May 13, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Disconnection” (3 reports).
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
- Disconnection3
- Detachment of Device or Device Component1
Patient problems
- Blood Loss3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE 2.5 FLOW PERMCATH CATHETER WAS USED FOR CONTRAST INJECTION. IN THE BLUE LUER IT WAS USED WITH A 3-WAY FAUCET, SINCE THE RED ROUTE RECEIVED SALINE SOLUTION. THE RED LUER WAS CLOSED AND THE BLUE LUER WAS OPENED, THE TAP WAS TURNED ON AT THE CONNECTION. WHEN PERFORMING THE TEST WITH SERUM IN THE INJECTOR WITH FLOW 2.5, THE TAPS AND THE WHITE PART OF THE CATHETER CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11819788 ↗MalfunctionJul 3, 2018Disconnection; Disconnection
ACCIDENTAL DISCONNECTION OF ARTERIAL LINE. BLOOD LOSS <20CC.
Patient problems: Blood Loss
MAUDE report 7660518 ↗MalfunctionJul 3, 2018Disconnection; Disconnection
ACCIDENTAL DISCONNECTION OF ARTERIAL LINE. BLOOD LOSS <20CC.
Patient problems: Blood Loss
MAUDE report 7660390 ↗MalfunctionJul 3, 2018Disconnection; Disconnection
ACCIDENTAL DISCONNECT OF ARTERIAL LINE. BLOOD LOSS 20-100CC.
Patient problems: Blood Loss
MAUDE report 7660325 ↗
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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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