Xcela H965451840Recalls & reported problems
Navilyst Medical, Inc. · 9.6F x 500mm Xcela Plastic Dual Lumen Power Injectable Port with Pre-Attached Polyurethane Catheter and Silicone Plug · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965451840), received between Oct 4, 2017 and Oct 6, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Decoupling” (1 report).
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
- Decoupling1
- Fracture1
- Migration or Expulsion of Device1
Patient problems
- Foreign Body In Patient1
- 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.
MalfunctionOct 6, 2017Decoupling; Decoupling
DURING PORT REMOVAL PROCEDURE IT WAS NOTED TUBING WAS NOT CONNECTED TO THE PORT. NO EVIDENCE OF THE TUBING IN THE CANAL OR IN THE NECK AREA. X-RAY REVEALED TUBING LOCATED IN RIGHT VENTRICLE. PATIENT REQUIRED ADDITIONAL PROCEDURE TO RETRIEVE THE TUBING.
Patient problems: Foreign Body In Patient
MAUDE report 6922385 ↗InjuryOct 4, 2017Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device
AS REPORTED BY HOSPITAL ON USER MEDWATCH # (B)(4): "EVENT DESCRIPTION: DURING PORT REMOVAL PROCEDURE IT WAS NOTED TUBING WAS NOT CONNECTED TO THE PORT - NO EVIDENCE OF TUBING IN CANAL OR IN NECK AREA. X-RAY REVEALED TUBING LOCATED IN RIGHT VENTRICLE. PATIENT REQUIRED ADDITIONAL PROCEDURE TO RETRIEVE TUBING. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? - PORT REMOVAL." FURTHER INFORMATION RECEIVED FROM THE HOSPITAL INDICATED THAT THE PORT HAD NOT BEEN ACCESSED AT THE HOSPITAL SINCE (B)(6) 2017. THE PATIENT REPORTED THAT IT HAD BEEN "ACCESSED LOCALLY IN (B)(6) 2017 WITHOUT ISSUE." THE PORT WAS BEING REMOVED BECAUSE OF END-OF-TREATMENT. IT HAS NOT BEEN CONFIRMED YET AS TO WHETHER THE DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6913281 ↗
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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