Xcela 44035Recalls & reported problems
Navilyst Medical, Inc. · Xcela Plus Titanium Port with Non-Filled Suture Holes and 8F x 63cm Polyurethane Catheter · Class 2 · Implant
All models of Xcela (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965440350), received between Oct 21, 2024 and Oct 21, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
- Chest Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PRODUCT, REFERENCE NUMBER H965440350, LOT NUMBER 5767870. THE DEVICE WAS IMPLANTED BY (B)(6) MD, AT (B)(6), FOR CHEMOTHERAPY ADMINISTRATION. ON OR ABOUT JULY 23, 2023, PLAINTIFF PRESENTED TO (B)(6) WITH CHEST PAINS AND WAS ADMITTED AFTER BLOOD CULTURES SHOWED GRAM POSITIVE COCCI AND STREPTOCOCCUS AGALACTIAE. HIS PHYSICIANS DETERMINED THE SOURCE OF THE INFECTION WAS THE XCELA PORT AND REQUIRED REMOVAL. ON OR ABOUT(B)(6) 2023 PLAINTIFF'S INFECTED PORT WAS REMOVED BY DR. (B)(6) MD AT (B)(6). AS A RESULT OF HAVING THE XCELA IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT TO LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.
Patient problems: Bacterial Infection; Chest Pain
MAUDE report 20493597 ↗
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- 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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