Manifold Recall: Medline Removes Namic Star Off Handle Manifolds 

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

The FDA is aware that Medline has issued a letter to affected customers recommending certain Namic Manifolds be removed from where they are used or sold. Affected devices:

• Namic Angiographic Manifold
• Namic Preceptor Manifold
• Namic Compensator Manifold
• Medline Convenience Kits containing Namic Manifolds

Full List of Affected Products

What to Do

Remove and destroy affected Namic Manifolds. Apply over-labels to all affected kits on hand stating that the affected manifolds must be removed and discarded from further use.

On March 24, Medline sent all affected customers a letter recommending the following actions:

• Immediately check your stock for any affected product and quarantine. Destroy affected product after completing recall response forms.
• Apply provided over-labels to any affected kits on hand stating that the affected manifolds must be removed and discarded from further use.
• If you are a distributor or have resold or transferred this product, notify them of this recall communication.
• If use is unavoidable because failure to proceed would result in patient harm, the Manifolds must be used with extreme caution and vigilance. In such cases:
  • The user should perform a full flush of the Manifold and associated tubing with saline.
  • Carefully examine the manifold and lines for any particulate.
  • Do not use the Manifold and lines if any particulate is observed.
  • Users should otherwise adhere to all usage guidelines and the Manifolds’ Instructions for Use.

Reason for Recall

Medline identified the presence of particulate within the fluid path of the Manifolds. Particulate within the Manifold fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels. This carries a risk of serious injury, such as tissue or organ ischemia, or death.

As of March 24, Medline has reported no serious injuries or deaths associated with this issue.

Device Use

The Namic Manifold is intended to be used for fluid management, contrast media and pressure monitoring.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medline at [email protected] or 866-359-1704.

Additional FDA Resources

1. FDA Enforcement Report
2. CDRH Medical Device Recall Database 

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

• Content current as of:

  05/26/2026

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