Pro-Line® CT MR28036201Recalls & reported problems
Medical Components, Inc. · 6F X 60CM DUAL LUMEN Pro-Line® CT W/CUFF @ 5CM BASIC IR SET · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908034622), received between Nov 16, 2017 and May 14, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2025Leak/Splash; Leak/Splash
NOTIFIED BY CHEMOTHERAPY UNIT THAT PRO-LINE LEAKING WHEN FLUSHED BUT NOT AT CONNECTOR, AT JUNCTION WHERE BOTH LUMENS ENTER SUTURE DEVICE (WHITE LUMEN). DEVICES ARE NEVER SUTURED, SECURACATH USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22019626 ↗MalfunctionNov 16, 2017Leak/Splash; Leak/Splash
CATHETER PLACED ON (B)(6). WORKED WELL WHEN PLACED. PATIENT RETURNED FOR EXCHANGE. CHEST X-RAY SHOWED DAMAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7037647 ↗
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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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