NexSite HD Hemodialysis Catheter NEXHD1552401Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05391525640006), received between Feb 2, 2016 and Jun 15, 2017 — classified as 1 death, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2017Aspiration Issue

  (B)(4). THE NEXSITE DEVICE WAS PLACED SUCCESSFULLY ON (B)(6) 2015. ON (B)(6) 2016, LACK OF ARTERIAL LIMB ASPIRATE WAS REPORTED. THE EVENT WAS MILD IN NATURE AND NO ACTION WAS TAKEN WITH THE STUDY DEVICE. CATHFLO WAS GIVEN AS A CLOTBUSTER AND THE EVENT HAD RESOLVED ON THE SAME DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6642657 ↗
• DeathNov 28, 2016Insufficient Device Problem Information

  ADDITIONAL INFORMATION PROVIDED BY THE SITE: THE DEATH CERTIFICATE INDICATED THAT THE SUDDEN CAUSE OF THIS NATURAL DEATH WAS A MYOCARDIAL INFARCTION. OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO THE DEATH INCLUDE CRF (CHRONIC RENAL FAILURE), HTN (HYPERTENSION), COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) AND ANEMIA.

  Patient problems: Death

  MAUDE report 6128405 ↗
• InjuryNov 17, 2016Insufficient Device Problem Information

  TR 0147 WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON 29 SEP 2016, A POTENTIAL CRBSI (CATHETER-RELATED BLOOD STREAM INFECTION) WAS REPORTED. "AT THE BEGINNING OF TREATMENT, PT TIRED AND BACK HURT, PT. ATTEMPTED TO REST BUT UNCOMFORTABLE, MIDWAY THRU TREATMENT SHE BEGAN VOMITING THICK MUCUS. GOAL DECREASED AND TREATMENT SHORTENED DUE TO DISCOMFORT. PT'S TEMP IS 100.6 MD CALLED, ORDER TO GIVEN VANCOMYCIN 1000MG AND FORTAZ 1000MG IV SLOWLY. AFTER BC FROM CATHETER, PT WEAK. DAUGHTER STATES SHE WILL TAKE TO ER IF WORSE, PT OUT TO CAR BY WC." HOWEVER, BLOOD CULTURES TAKEN ON THE SAME DAY SHOWED NO GROWTH AFTER 5 DAYS ON INCUBATION. THE EVENT WAS CONSIDERED RESOLVED (B)(6) 2016 AND ANTIBIOTICS WERE STOPPED. NO ACTION WAS TAKEN WITH THE STUDY DEVICE.

  Patient problems: Discomfort; Fatigue; Fever; Pain; Vomiting

  MAUDE report 6108793 ↗
• InjuryJun 16, 2016Appropriate Device Problem Term/Code Not Available

  (B)(4): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2015. THE CATHETER WAS REMOVED ON (B)(6) 2015 AS IT WAS NO LONGER REQUIRED. THE DACRON WAS LEFT IN THE SUBJECT AND WAS REPORTED TO FORM A NON-HEALING WOUND IN THE CHEST WALL WITH PURULENT DRAINAGE. THE DACRON WAS REMOVED ON (B)(6) 2016 AND THE SUBJECT WAS GIVEN CEFTAZIDIME 200MG AND VANCOMYCIN HCI 1500MG AT THE DIALYSIS UNIT. BLOOD CULTURES WERE DRAWN ON (B)(6) 2016 AND THEY WERE NEGATIVE. THERE WERE NO WOUND CULTURES TAKEN. THE PATIENT HAD RECOVERED BY (B)(6) 2016.

  Patient problems: Purulent Discharge

  MAUDE report 5728534 ↗
• InjuryApr 4, 2016Device Handling Problem

  (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY IMPLANTED IN A (B)(6) YEAR OLD FEMALE ON (B)(6) 2016. THE PATIENT DEVELOPED BRUISING AND PAIN AROUND THE CATHETER SITE UPON HER RETURN HOME FROM CATHETER PLACEMENT. ON (B)(6) 2016, THE PATIENT PRESENTED TO ED WITH BLEEDING AND PAIN AT THE CATHETER SITE, CHEST PAIN AND AN IRREGULAR HEART BEAT. THE PATIENT WAS HOSPITALISED BUT NO TREATMENT WAS GIVEN. NO ACTION WAS TAKEN WITH THE STUDY DEVICE. THE EVENT HAD RESOLVED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT HAD SEVERE FEVER AND CHILLS WITH A POSSIBLE RELATIONSHIP TO THE STUDY DEVICE. THE PATIENT WAS HOSPITALISED. PERIPHERAL AND CENTRAL BLOOD CULTURES AND URINE CULTURES WERE TAKEN ON (B)(6) 2016 AND ALL WERE NEGATIVE FOR BACTERIAL GROWTH. CEFEPIME, CIPROFLOXACIN, VANCOMYCIN AND LEVOFLOXACIN WERE ADMINISTERED. ON (B)(6) 2016, COAGULASE NEGATIVE STAPHYLOCOCCUS WAS NOTED IN THE BLOOD SAMPLE COLLECTED FROM THE CENTRAL LINE. THE PATIENT WAS DISCHARGED ON (B)(6) 2016 AND THE FEVER AND CHILLS HAD RESOLVED. DISCHARGE DIAGNOSIS WAS SEPSIS DUE TO FEVER, TACHYPNEA AND TACHYCARDIA. ONE OF FOUR BLOOD CULTURES WAS POSITIVE FOR COAGULASE NEGATIVE STAPHYLOCOCCUS. THE SOURCE OF THE INFECTION WAS UNCLEAR AND

  Patient problems: Bruise/Contusion; Chest Pain; Fever; Hemorrhage/Blood Loss/Bleeding; Increased Respiratory Rate; Pain; Sepsis; Staphylococcus Aureus; Tachycardia

  MAUDE report 5543761 ↗
• MalfunctionFeb 2, 2016Improper Flow or Infusion

  STUDY (B)(6): THIS (B)(6) OLD PATIENT HAD A NEXSITE DEVICE PLACED SUCCESSFULLY ON (B)(6) 2015. ON (B)(6) 2016, THE DEVICE HAD MODERATE POOR FLOW. NO ACTION WAS TAKEN WITH THE STUDY DEVICE. ACTIVASE WAS GIVEN TO TREAT THE EVENT. THE EVENT RESOLVED ON THE SAME DAY. THERE WAS A SECOND OCCURRENCE OF MODERATE LOW FLOW ON (B)(6) 2016. ACTIVASE WAS GIVEN AGAIN AND THE EVENT HAD RESOLVED BY (B)(6) 2016. NO ACTION WAS TAKEN WITH THE STUDY DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5403565 ↗