Pro-Fuse® CT Port MRCTT80001Recalls & reported problems
Medical Components, Inc. · 8F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER · 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 00884908031379), received between Jul 30, 2020 and Oct 19, 2023 — 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- Extravasation1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2023Leak/Splash; Leak/Splash
PORT LUMEN LEAKED APPROXIMATELY 5 CM FROM THE PORT STEM.
Patient problems: Extravasation; Pain
MAUDE report 17964545 ↗MalfunctionJul 30, 2020Leak/Splash; Leak/Splash
THE PORT WAS IMPLANTED FOR APPROXIMATELY 1 YEAR. APPROXIMATELY 2 MONTHS AGO AFTER INFUSION OF 5FU THE PATIENT EXPERIENCED SOME REDNESS AROUND THE PORT SITE. DURING THE NEXT ACCESS NURSES HAD TO INSERT TPA AS THEY COULD NOT ASPIRATE. THE SECOND TIME PATIENT REDNESS OCCURRED THE DOCTOR REMOVED THE PORT AND MANAGED TO PINCH OFF THE CATHETER AND INFUSE SALINE INTO THE PORT. THIS IS WHEN A LEAK IN THE PORT WAS NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10344477 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices
- PowerPort M.R.I., Groshong 9808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 deaths834 reports
- PowerPort ClearVUE 1608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 deaths571 reports
- PowerPort ClearVUE 5608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR31 deaths542 reports
- PowerPort M.R.I., ChronoFlex 1808000Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR19 deaths513 reports
- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
- PowerPort M.R.I., Groshong 1808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
- BardPort M.R.I. 0602680Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths179 reports
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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