Xcela H965440400Recalls & reported problems
Angiodynamics, Inc. · Xcela Plus Plastic Port with PASV Valve Technology (Filled Suture Holes) and 8F x 63cm Polyurethane Catheter · Class 2 · Implant
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 15051684018883), received between Dec 17, 2025 and Dec 17, 2025 — 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
- Chest Pain1
- Pulmonary Embolism1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON OR ABOUT ON (B)(6) 2023, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PORT PRODUCT, REFERENCE NUMBER: H965440400, LOT NUMBER: 5795892. THE DEVICE WAS IMPLANTED BY (B)(6), DO, AT (B)(6), FOR CHEMOTHERAPY ADMINISTRATION. ON OR ABOUT ON (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) CENTER WITH CHEST PAINS. AS A RESULT, A DOPPLER ULTRASOUND WAS ORDERED AND LATER SHOWED A THROMBOSIS AT OR NEAR THE RIGHT INTERNAL JUGULAR, SUBCLAVIAN, AXILLARY, AND/OR BRACHIAL VEINS. ON OR ABOUT ON (B)(6) 2024, PLAINTIFF WAS DIAGNOSED WITH A PULMONARY EMBOLUS FOLLOWING A CT SCAN. ON OR ABOUT ON (B)(6) 2024, PLAINTIFF'S PORT WAS REMOVED BY DR. (B)(6), MD AT (B)(6) CENTER.
Patient problems: Chest Pain; Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 23831256 ↗
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- 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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