Xcela H965440320Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15051684018821), received between Mar 23, 2025 and Jun 9, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “No Flow” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026No Flow

  ON OR ABOUT (B)(6), 2020, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA POWER INJECTABLE PORT CATHETER DEVICE, WITH MODEL NUMBER H965440320, AND LOT NUMBER 5545434. THE DEVICE WAS IMPLANTED BY DR. (B)(6) AT (B)(6) MEDICAL CENTER, MISSOURI FOR CHEMOTHERAPY ADMINISTRATION TO TREAT PLAINTIFF'S CANCER. ON OR ABOUT(B)(6) 2022, PLAINTIFF PRESENTED TO THE RADIOLOGY DEPARTMENT AT (B)(6) MEDICAL CENTER, MISSOURI WITH COMPLAINTS OF EXTREME PAIN, INABILITY FOR THE PORT TO ACCEPT INFUSIONS, AND AN INABILITY FOR THE PORT TO PRODUCE A BLOOD RETURN AS REQUIRED FOR HIS CHEMOTHERAPY INFUSIONS. STUDIES WERE CONDUCTED AND IT WAS DETERMINED THERE WAS AN OCCLUSION AND THE FORMATION OF A FIBRIN SHEATH. ON OR ABOUT (B)(6) 2022, A PROCEDURE WAS PERFORMED ON PLAINTIFF'S BY DR. (B)(6) STRIPPING AWAY THE FIBRIN SHEATH AND ADDRESSING THE OCCLUSION AT (B)(6) MEDICAL CENTER, MOSSOURI.

  Patient problems: Pain

  MAUDE report 25452047 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIOR TO (B)(6) 2022, PLAINTIFF (B)(6) WAS DIAGNOSED WITH CANCER. THE TREATMENT FOR PLAINTIFF'S CANCER INCLUDED CHEMOTHERAPY. IN ORDER TO ADMINISTER THE CHEMOTHERAPY MEDICATIONS TO PLAINTIFF, HER PHYSICIANS HAD A PORT-A-CATHETER PLACED IN HER RIGHT UPPER CHEST. ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING ANGIODYNAMICS' PORT XCELA PLUS, INVENTORY ITEM: PORT IMP INF XCELA PLUS, PLAS 8.0F 63CM, IMPLANT NAME: PORT XCELA PLUS, 8FR-LOG242721, MODEL/CAT NO.: 44-032, MANUFACTURER: ANGIODYNAMICS, FOR THE PURPOSES OF PLAINTIFF'S CHEMOTHERAPY. ON OR ABOUT (B)(6) 2022, THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6) AT (B)(6) FOR THE PURPOSES INDICATED ABOVE. THE DEFENDANTS, DIRECTLY OR THROUGH THEIR AGENTS, APPARENT AGENTS, SERVANTS, OR EMPLOYEES, DESIGNED, MANUFACTURED, MARKETS, ADVERTISED, DISTRIBUTED, AND SOLD THE PORT XCELA PLUS THAT WAS IMPLANTED IN (B)(6). UPON INFORMATION AND BELIEF, ON (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER IN (B)(6) WHERE PLAINTIFF WAS SEEN FOR BLOOD IN HER CHEMOTHERAPY PORT AND WAS TREATED FOR ULCERATIONS AND REDNESS AT THE PORT SITE WITH ANTIBIOTICS. UPON INFORMATION AND BELIEF, PLAINTIFF HAD BEEN TREATED PREVIOUSLY FO

  Patient problems: Pocket Erosion

  MAUDE report 22844854 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIOR TO (B)(6) 2022, PLAINTIFF (B)(6). WAS DIAGNOSED WITH CANCER. THE TREATMENT FOR PLAINTIFF'S CANCER INCLUDED CHEMOTHERAPY. IN ORDER TO ADMINISTER THE CHEMOTHERAPY MEDICATIONS TO PLAINTIFF, HER PHYSICIANS HAD A PORT-A-CATHETER PLACED IN HER RIGHT UPPER CHEST. ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING ANGIODYNAMICS' PORT XCELA PLUS, INVENTORY ITEM: PORT IMP INF XCELA PLUS, PLAS 8.0F 63CM, IMPLANT NAME: PORT XCELA PLUS, 8FR-LOG242721, MODEL/CAT NO.: 44-032, MANUFACTURER: ANGIODYNAMICS, FOR THE PURPOSES OF PLAINTIFF'S CHEMOTHERAPY. ON OR ABOUT (B)(6) 2022, THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6) HOSPITAL FOR THE PURPOSES INDICATED ABOVE. THE DEFENDANTS, DIRECTLY OR THROUGH THEIR AGENTS, APPARENT AGENTS, SERVANTS, OR EMPLOYEES, DESIGNED, MANUFACTURED, MARKETS, ADVERTISED, DISTRIBUTED, AND SOLD THE PORT XCELA PLUS THAT WAS IMPLANTED IN (B)(6). UPON INFORMATION AND BELIEF, ON (B)(6), 2022, PLAINTIFF PRESENTED TO (B)(6) WHERE PLAINTIFF WAS SEEN FOR BLOOD IN HER CHEMOTHERAPY PORT AND WAS TREATED FOR ULCERATIONS AND REDNESS AT THE PORT SITE WITH ANTIBIOTICS. UPON INFORMATION AND BELIEF, PLAINTIFF HAD BEEN TREATED PREVIOUSLY FOR AN INFECTION AT HER PO

  Patient problems: Medical device site infection; Pocket Erosion

  MAUDE report 22844104 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA POWER INJECTABLE PORT CATHETER PRODUCT, WITH MODEL NUMBER H965440320, AND LOT NUMBER 5645799. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6). THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF CHEMOTHERAPY TO TREAT PLAINTIFF'S BREAST CANCER. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO ADVENTHEALTH OCALA IN OCALA, FLORIDA, WITH COMPLAINTS OF LEG SWELLING AND SWELLING IN THE RIGHT ARM AND IN THE CHEST, AS WELL AS CHEST WALL PAIN. BASED ON PLAINTIFF'S SYMPTOMS, PLAINTIFF'S TREATING MEDICAL PROVIDERS ORDERED A NECK CT, WHICH PLAINTIFF UNDERWENT ON (B)(6) 2022, WHICH REVEALED CATHETER-ASSOCIATED THROMBUS AT THE RIGHT SUPERIOR VENA CAVA AS WELL AS OCCLUSION OF THE SUPERIOR VENA CAVA. PLAINTIFF WAS SUBSEQUENTLY DIAGNOSED WITH SUPERIOR VENA CAVA (SVC) SYNDROME AND THROMBOSIS OF THE RIGHT-SIDED CHEST PORT. ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT REMOVAL OF THE XCELA PORT SECONDARY TO THE DIAGNOSES OF THROMBOSIS AND SVC SYNDROME. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D, AT (B)(6).

  Patient problems: Chest Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 22464943 ↗
• InjuryMar 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2021, DECEDENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PRODUCT, MODEL NUMBER H9654403205, LOT NUMBER 5640621. THE DEVICE WAS IMPLANTED BY DR. (B)(6) FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2022, DECEDENT PRESENTED TO (B)(6) WITH COMPLAINTS OF A SYNCOPAL EPISODE, LETHARGY, COUGH, AND INCREASED WEAKNESS. DECEDENT'S MEDICAL TEAM DETERMINED THAT SHE HAD DEVELOPED AN INFECTION AND THAT THE XCELA WAS THE SOURCE. ON OR ABOUT (B)(6) 2022, DECEDENT'S DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6).

  Patient problems: Cough; Lethargy; Muscle Weakness/Atrophy; Syncope/Fainting; Unspecified Infection

  MAUDE report 21673671 ↗