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NexSite HD Hemodialysis Catheter NEXHD1553601Recalls & reported problems

Marvao Medical Devices Limited · The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05391525640068), received between Jul 5, 2016 and Jul 6, 2016 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow 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 18, 2026.

Most reported problems

Device problems

  • Infusion or Flow Problem1
  • Malposition of Device1
  • Positioning Problem1

Patient problems

  • Bacterial Infection1
  • Chest Pain1
  • Fever1
  • Staphylococcus Aureus1

Recent adverse event reports

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

  • InjuryJul 6, 2016Malposition of Device

    (B)(4): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED IN THIS PATIENT ON (B)(6) 2016. ON (B)(6) 2016, MILD MALPOSITION OF HER CATHETER WITH INABILITY TO RUN HER DIALYSIS TREATMENT WAS REPORTED. THE SAME CATHETER REMAINED, THE CATHETER WAS JUST UNTWISTED AND REPOSITIONED. THE EVENT RESOLVED ON THE SAME DATE. ON (B)(6) 2016, THE PATIENT EXPERIENCED MILD BACTEREMIA WITH (B)(6) OF UNKNOWN PRIMARY. THE PATIENT HAD A FEVER AND WBCS OF 21.4. PERIPHERAL BLOODS SHOWED (B)(6) WHILE CENTRAL BLOODS WERE NOT TAKEN. WHILE THE SOURCE OF THE BACTEREMIA WAS UNKNOWN, A UTI OR PNEUMONIA WAS SUSPECTED. THE EXIT SITE WAS CLEAN, THE TUNNEL TRACT WAS CLEAN AND WHEN THE ANTIBIOTICS WERE DISCONTINUED, THE CATHETER WAS STILL BEING USED WITHOUT PROBLEMS. VANCOMYCIN AS GIVEN TO TREAT THE EVENT AND THE EVENT RESOLVED ON (B)(6) 2016.

    Patient problems: Bacterial Infection; Fever; Staphylococcus Aureus

    MAUDE report 5771530 ↗
  • MalfunctionJul 5, 2016Infusion or Flow Problem; Positioning Problem

    (B)(4): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2016, MODERATE POSITIONAL RELATED FLOW ISSUES OCCURRED. CATHFLO ACTIVASE WAS GIVEN TO TREAT THE EVENT. THE PATIENT ALSO EXPERIENCED CHEST PAIN RADIATING TO RIGHT ARM ON (B)(6) 2016 AND WAS HOSPITALISED FOR THIS EVENT TO RULE OUT MYOCARDIAL INFARCTION. A CARDIAC ECHO WAS COMPLETED ON (B)(6) 2016. SUBJECT HAD THREE SETS OF CARDAIC ENZYMES THAT WERE NEGATIVE. A CHEST X-RAY SHOWED AN INFILTRATE IN THE RIGHT BASE. THE NOTE STATES THAT THIS WAS COVERED WITH ANTIBIOTICS GIVEN HER RECENT HOSPITAL ADMISSIONS. THE HOSPITAL NOTE ALSO STATES THAT THE RIGHT CHEST DIALYSIS ACCESS CATHETER SITE APPEARED HEALTHY. LEVAQUIN, LINODIL AND ZOSYN WERE GIVEN TO TREAT THIS HOSPITAL-ACQUIRED INFECTION. THE PATIENT WAS DISCHARGED ON (B)(6) 2016 AND THE CHEST PAIN EVENT HAD FULLY RESOLVED. THIS EVENT WAS UNRELATED TO THE STUDY DEVICE. THE DEVICE WAS REMOVED ON (B)(6) 2016 DUE TO POSITIONAL RELATED FLOW ISSUES. THE EVENT HAD FULLY RESOLVED.

    Patient problems: Chest Pain

    MAUDE report 5768492 ↗

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Sources and updates

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