Xcela H965451810Recalls & reported problems
Navilyst Medical, Inc. · 9.6F x 500mm Xcela Plastic Dual Lumen Power Injectable Port with Attachable Polyurethane Catheter · Class 2 · Implant
All models of Xcela (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965451810), received between Aug 9, 2017 and Sep 20, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Material Deformation1
Patient problems
- Bruise/Contusion1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2017Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
PORT LEAKED IN PATIENT - ACCESSED ON SIDE OF PORT AND PATIENT IMMEDIATELY BRUISED.
Patient problems: Bruise/Contusion
MAUDE report 6878633 ↗InjuryAug 9, 2017Fluid/Blood Leak; Fluid/Blood Leak
EVENT CALLED IN BY THE MOTHER OF THE PATIENT. AN XCELA POWER INJECTABLE PORT WAS REMOVED ON (B)(6) 2017. THE REPORTED DESCRIPTION OF THE EVENT WAS : " PORT LEAKED IN PATIENT - ACCESSED ON SIDE OF PORT ON ((B)(6) AND PATIENT IMMEDIATELY BRUISED." THE PORT WAS REMOVED AT CHILDREN'S HOSPITAL OF ORANGE COUNTY AND THEY HAVE RETURNED THE DEVICE TO ANGIODYNAMICS.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6777833 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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