Xcela 44032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965440320), received between Jul 17, 2024 and Mar 10, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT ON (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX IMPLANTABLE PORT, MODEL NUMBER: H787P5455K0, LOT NUMBER: 5670753. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), TO FACILITATE CHEMOTHERAPY TREATMENT. ON OR ABOUT ON (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6), WITH COMPLAINTS OF A FEVER. ON OR ABOUT ON (B)(6) 2023, PLAINTIFF RECEIVED A CALL FROM HER DOCTOR THAT HER BLOOD CULTURES DRAWN ON (B)(6) 2023, CAME BACK POSITIVE FOR A BACTERIAL INFECTION, AND THAT SHE NEEDS TO GO TO THE EMERGENCY ROOM. ON OR ABOUT ON (B)(6) 2023, PLAINTIFF PRESENTED TO THE EMERGENCY ROOM AT (B)(6), FOR FURTHER EVALUATION AS DIRECTED BY HER DOCTOR. AFTER EVALUATION, PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE VORTEX WAS THE SOURCE OF THE INFECTION AND THAT THE IMPLANT NEEDED TO BE REMOVED. ON OR ABOUT ON (B)(6) 2023, DUE TO HER INFECTED VORTEX PORT CATHETER, PLAINTIFF UNDERWENT SURGICAL REMOVAL OF THE DEFECTIVE DEVICE, WHICH WAS REMOVED BY (B)(6), M.D., AT (B)(6).

  Patient problems: Bacterial Infection; Fever

  MAUDE report 21560507 ↗
• InjuryMar 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT, REFERENCE NUMBER (B)(4), LOT NUMBER 5737583. THE DEVICE WAS IMPLANTED BY (B)(6), MD, AT (B)(6), FOR THE PURPOSE OF ONGOING VEIN ACCESS. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED HERSELF TO (B)(6) WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO MALFUNCTIONING AND AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21559745 ↗
• MalfunctionJul 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AN END USER REPORTED AN ISSUE WITH AN XCELA, 8F SINGLE PLASTIC PORT FILLED NON-VALVED. DURING CHEMOTHERAPY TREATMENT, THE PORT WAS INFILTRATED AND LEAKED WITHIN THE PATIENT. THE PATIENT HAD A PORT REMOVAL PROCEDURE SCHEDULED FOR (B)(6) 2024. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL DETAILS, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Infiltration into Tissue

  MAUDE report 19762788 ↗