NexSite HD Hemodialysis Catheter NEXHD1555501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05391525640105), received between Nov 16, 2015 and Apr 29, 2016 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2016Contamination

  STUDY (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016 IN THE RIGHT FEMORAL VEIN. THIS (B)(6) OLD FEMALE HAD NO ISSUES UNTIL (B)(6) 2016 WHEN RN FOUND YELLOW EXUDATE AT CATHETER EXIT SITE WHILE CHANGING DRESSING. PATIENT HAD NO COMPLAINTS OF FEVER OR CHILLS, NO ABNORMAL VITAL SIGNS. PATIENT DENIED DRAINAGE AT EXIT SITE PREVIOUS TO RN ASSESSMENT. ACCESS RUNNING WELL. EXIT SITE CULTURE TAKEN ON (B)(6) 2016. STAPH EPIDERMIDIS POSITIVE CULTURE RESULT ON (B)(6) 2016. PATIENT STARTED ON VANCO 1000MG IV QHD PER SENSITIVITY REPORT AND SENT TO RAC FOR NEXSITE REMOVAL. PATIENT SEEN AT RAC ON (B)(6) 2016. PER RAC REPORT, PURULENT DRAINAGE NOTED AT EXIT SITE AS WELL AS ABSCESS. CATHETER REMOVED. NEW RIGHT FEMORAL CANNON CATHETER WAS PLACED. PATIENT REMAINS PC DEPENDENT AS NO OTHER OPTIONS FOR AVG/AVF OR HERO. THERE WERE NO BLOOD CULTURES DRAWN AS ASSESSMENT BENIGN WITH EXCEPTION OF EXIT SITE EXUDATE. PATIENT HAS NOT BEEN HOSPITALIZED RECENTLY, NOR HAS SHE HAD ANY POSITIVE BLOOD CULTURES. LAST CULTURE DRAWN IN CENTER (B)(6) 2015 WHICH WAS NEGATIVE FOR GROWTH.

  Patient problems: Bacterial Infection; Purulent Discharge

  MAUDE report 5619119 ↗
• MalfunctionNov 16, 2015Appropriate Device Problem Term/Code Not Available

  (B)(4): THIS (B)(6) FEMALE PATIENT HAD A NEXSITE DEVICE PLACED IN THE RIGHT FEMORAL VEIN ON (B)(6) 2015. THE CATHETER WAS EXCHANGED WITH A NON-NEXSITE CATHETER OVER A WIRE AT A LOCAL HOSPITAL DUE TO "DYSFUNCTIONAL CATHETER" ON (B)(6) 2015. THERE WERE NO SPECIFICS AS TO WHETHER THEY COULDN'T ASPIRATE OR IF IT WAS AN INADEQUATE BLOOD FLOW. THERE WAS NO RECORD OF DISC REMOVAL. THE PATIENT WAS ADMITTED ON (B)(6) 2015 WITH POSITIVE BLOODS ((B)(6)), PAIN IN RIGHT LOWER EXTREMITY AND FEVERS. A CT OF THE RIGHT LOWER EXTREMITY SHOWED A CURVILINEAR FOREIGN BODY, SUSPECTED TO BE AND EVENTUALLY CONFIRMED AS RETAINED DISC FROM STUDY CATHETER IN THE RIGHT UPPER ANTERIOR THIGH. ALSO ADJACENT FLUID COLLECTION AND ADENOPATHY WITH OVERLYING SKIN INFLAMMATION. THE CATHETER WAS REMOVED AT BEDSIDE ON (B)(6) 2015. VASCULAR SURGEON DID INCISION AND DRAINAGE ON (B)(6) 2015 AND REMOVED THE DISC. THE PATIENT WAS INITIALLY PLACED ON VANCOMYCIN AND ZOSYN AND THIS WAS CHANGED TO VANCOMYCIN ONLY AND CONTINUED UNTIL (B)(6) 2015. FOLLOW UP CULTURES WERE NEGATIVE PRIOR TO DISCHARGE FROM HOSPITAL. A TUNNELLED DIALYSIS CATHETER WAS PLACED IN LEFT FEMORAL. THE CURRENT CONDITION OF THE PATIENT IS STABLE.

  Patient problems: Bacterial Infection; Fever; Inflammation; Pain; Staphylococcus Aureus

  MAUDE report 5225263 ↗