Pro-Line® CT MR28036221Recalls & reported problems
Medical Components, Inc. · 6F X 60CM DUAL LUMEN Pro-Line® CT W/ CUFF @ 2CM BASIC IR SET · Class 2 · Implant
Data updated Oct 18, 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 00884908094275), received between Jul 13, 2017 and Jun 7, 2018 — 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 18, 2026.
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2018Leak/Splash; Leak/Splash
DEFECT (WEAKENING OF THE CATHETER WALL CAUSING A BALLOON) . INCIDENTAL FINDING ON A CHEST X-RAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7578773 ↗MalfunctionJul 13, 2017Leak/Splash; Leak/Splash
AFTER CATHETER WAS PLACED A PIN HOLE WAS NOTICED JUST BELOW THE HUB. THE CATHETER WAS REMOVED AND A NEW CATHETER PLACED. THE PATIENT WAS NOT IMPACTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6710323 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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