Dignity® Low Profile CT Port MRCTI66041Recalls & reported problems
Medical Components, Inc. · 6.6F PLASTIC DIGNITY® LOW PROFILE CT PORT W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER · Class 2 · Implant
All models of Dignity Low Profile CT Port (4)
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 00884908031157), received between Mar 22, 2019 and Apr 22, 2021 — 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
- Extravasation1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2021Leak/Splash; Leak/Splash
THE CONTRAST MEDIUM INJECTED INTO THE RESERVOIR SHOWED LEAKAGE JUST IN THE PROXIMAL PORTION ADJACENT TO IT IN THE PECTORAL REGION, AN UPPER PATH APPARENTLY EXTERNAL TO THE CATHETER WAS ALSO OBSERVED, WITH A GREATER QUANTITY FLOWING TO THE CERVICAL REGION. THESE FINDINGS SUGGEST IMPAIRMENT OF THE RESERVOIR OR EVEN THE PROXIMAL PORTION OF THE CATHETER, WHICH MAY BE RELATED TO OBSTRUCTION, FRACTURE OR EVEN DISCONNECTION.
Patient problems: Insufficient Information
MAUDE report 11709637 ↗MalfunctionMar 22, 2019Leak/Splash; Leak/Splash
X-RAY REVEALED EXTRAVASATION OF CONTRAST AROUND THE DRUM DURING INFUSION.
Patient problems: Extravasation
MAUDE report 8445184 ↗
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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