Xcela H965451030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965451030), received between Nov 3, 2017 and Jun 3, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• InjuryJun 3, 2026Appropriate Device Problem Term/Code Not Available

  ON OR ABOUT (B)(6), 2016, PATIENT UNDERWENT PLACEMENT OF THE ANGIODYNAMICS XCELA POWER INJECTABLE PORT, LOT NUMBER 135896000, REFERENCE NUMBER H965451030. THE DEVICE WAS IMPLANTED BY (B)(6), MD, AT (B)(6), COLORADO, FOR THE PURPOSE OF CHEMOTHERAPY. ON OR ABOUT (B)(6), 2017, PATIENT WAS PRESENTED TO (B)(6) HOSPITAL IN (B)(6), COLORADO WHERE PATIENT WAS DIAGNOSED WITH PULMONARY EMBOLISM. THE PORT WAS LATER REMOVED ON (B)(6), 2018 AT THE SAME HOSPITAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25382313 ↗
• InjuryJul 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON OR ABOUT (B)(6) 2013, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA POWER INJECTABLE PORT CATHETER PRODUCT, MODEL NUMBER H965451030, LOT NUMBER 121584000. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D.(B)(6) HOSPITAL IN (B)(6). THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ONGOING VENOUS ACCESS. ON OR ABOUT (B)(6) 2013, PATIENT PRESENTED TO (B)(6) HOSPITAL IN (B)(6), WITH COMPLAINTS OF A REDNESS, TENDERNESS, AND PAIN OVER THE LEFT CHEST, SHOULDER, AND NECK AREA. PATIENT'S MEDICAL TEAM DETERMINED THAT HE HAD DEVELOPED AN INFECTION. ON OR ABOUT (B)(6) 2013, PATIENT'S INFECTED PORT WAS REMOVED BY DR. (B)(6), M.D., (B)(6) HOSPITAL. AT NO POINT DID PATIENT'S HEALTHCARE TEAM INDICATE TO HIM THAT THE XCELA FAILED OR WAS DEFECTIVE. PATIENT'S HEALTHCARE PROVIDERS DID NOT STATE THAT THE XCELA WAS THE CAUSE OF THE INFECTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22671548 ↗
• InjuryNov 3, 2017Use of Device Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Use of Device Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  PATIENT EXPERIENCED A HEMOPNEUMOTHORAX WHICH DR. BELIEVES IS DUE TO THE J WIRE GETTING CAUGHT IN THE PATIENT PRIOR TO INSERTING THE CATHETER. OPERATIVE NOTE: AFTER INFORMED CONSENT WAS OBTAINED, THE PATIENT WAS TAKEN TO THE OPERATING ROOM, PLACED SUPINE ON THE OR TABLE, GENERAL ENDOTRACHEAL ANESTHESIA WAS INDUCED, BILATERAL CHEST AND NECK WERE PREPPED AND DRAPED IN STANDARD SURGICAL FASHION. THE PATIENT RECEIVED PREOPERATIVE ANTIBIOTICS AND THE SCDS WERE PLACED. AFTER A TIMEOUT WAS PERFORMED, THE PATIENT WAS PLACED IN REVERSE TRENDELENBURG POSITION. USING A SELDINGER TECHNIQUE, THE RIGHT SUBCLAVIAN VEIN WAS ENTERED AT THE FIRST ATTEMPT. ULTRASOUND WAS USED TO SEE THE VEIN INITIALLY THOUGH NOT AT TIME OF ENTRY, THERE WAS VENOUS BLOOD RETURNED AND A GUIDEWIRE WAS PLACED THROUGH THE NEEDLE AND THE NEEDLE WAS REMOVED. FLUORO WAS INSTITUTED AND THE GUIDEWIRE ACTUALLY TRAVERSED ACROSS TO THE SUBCLAVIAN VEIN ON THE CONTRALATERAL SIDE. THE GUIDEWIRE WAS ATTEMPTED TO BE REMOVED UNDER DIRECT FLUOROSCOPIC GUIDANCE, BUT WAS PULLED BACK TOO FAR INTO THE SUBCUTANEOUS TISSUE AND THEREFORE WAS REMOVED AND PRESSURE HELD IN THE SUBCLAVIAN REGION. AFTER A COUPLE MINUTES, ANOTHER ATTEMPT WAS MADE AT T

  Patient problems: Hemothorax; Patient Problem/Medical Problem; Pneumothorax; Tachycardia

  MAUDE report 7000304 ↗