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Acute Dual Lumen Hemodialysis Catheter
Summary: The acute dual lumen hemodialysis catheter by Health Line International is used for temporary vascular access in dialysis. Key evidence highlights design features impacting infection risks.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K200426 ↗
Decision Date ?
December 24, 2020
Product Code ?
MPB Catheter, Hemodialysis, Non-Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on December 24, 2020, by Health Line International. It is classified as a Class 2 device under product code MPB.
What It Is
The acute dual lumen hemodialysis catheter is a non-tunneled device designed for short-term vascular access in patients requiring hemodialysis. It facilitates efficient blood flow for dialysis procedures.
FDA-Cleared Indications
- Temporary vascular access for hemodialysis.
- Use in patients who require short-term extracorporeal blood treatment.
- The catheter is intended for non-implanted, acute vascular access rather than permanent dialysis access.
Clinical Applications
- Urgent hemodialysis in hospitalized patients with acute kidney injury.
- Short-term dialysis access when an arteriovenous fistula or graft is not available or cannot be used.
- Hemodialysis while awaiting placement or maturation of more durable vascular access.
- Extracorporeal blood treatment in an acute-care setting when the catheter is used according to its labeling.
Reported off-label uses
- Short-term vascular access for continuous renal replacement therapy in an intensive care unit.
- Short-term access for plasma exchange or other extracorporeal blood therapies when the catheter configuration and flow requirements are appropriate.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 15 studies, comprising RCTs, prospective, and retrospective analyses, published between 2022 and 2025. These studies evaluate design features, usage trends, and associated risks.
Reported Outcomes
Published studies report that the design features of dual lumen catheters, such as lumen number and material, can influence infection rates. The use of real-time ultrasound during insertion reduces mechanical complications.
Safety Profile
Reported complications include infection and mechanical issues related to catheter insertion. The use of ultrasound guidance has been shown to mitigate some of these risks.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials specifically comparing dual lumen catheters to other designs. Further research is needed to explore long-term outcomes and safety.
Practical Considerations
- Common insertion sites include the right internal jugular vein; femoral or left internal jugular access may be considered when clinically appropriate. Subclavian access is generally avoided when future permanent dialysis access is possible because of the risk of central venous stenosis.
- Available catheter lengths and French sizes vary by product configuration and patient anatomy. The selected size should provide adequate dialysis blood flow while limiting insertion-related trauma.
- Placement is typically performed using ultrasound guidance, with imaging confirmation of the catheter tip before use. Catheter lumens should be flushed, clamped and locked according to the product instructions and institutional protocol.
- This is a short-term catheter, not a substitute for a mature arteriovenous fistula or graft. Infection, thrombosis, bleeding, air embolism, vessel injury and catheter malfunction are important risks.
- MRI conditions depend on the exact catheter model and its labeling. Confirm MR Safe, MR Conditional or MR Unsafe status before an MRI; do not assume that all acute dialysis catheters have the same MRI restrictions.
Frequently Asked Questions
What are the clinical indications for acute dual lumen hemodialysis catheter?
The catheter is indicated for temporary vascular access in patients requiring hemodialysis, particularly in cases of acute kidney injury.
What outcomes have been reported in clinical studies?
Studies report that catheter design features can impact infection rates and that ultrasound guidance reduces mechanical complications.
What complications have been reported?
Safety data indicate risks of infection and mechanical complications, though ultrasound guidance can reduce these issues.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.