Anesthesia Breathing Circuit Kit Correction: Draeger, Inc. Updates Use Instructions for VentStar Flex and Anesthesia Circuit Kits Due to Cracks in Hose That May Cause Inadequate Ventilation

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

What to Do

• Follow updated Instructions for Use.
• Perform a leak test before every use of these breathing circuits, after stretching the hose to the required length, to check for cracks or leaks.
• Use hose holders with a larger contact surface to avoid creating cracks in the hose.
• Do not use any breathing circuit that shows signs of damage or fails the leak test.

On March 3, 2025, Draeger, Inc. sent all affected customers an Urgent Medical Device Notification recommending the following actions when using these breathing circuits:

• Use holders with a larger contact surface.
• Perform leak testing after stretching the flexible hose to the required length for the application. Please observe the products Instructions for Use.
• Inspect all inventory for affected products and ensure all device users in your facility are aware of the updated use instructions.
• If you have distributed affected products to other locations, forward this correction notice to those users.
• Report any device malfunctions or adverse events to FDA MedWatch and Draeger Customer Service.

Reason for Updates to Use Instructions

Draeger, Inc. is updating the use instructions on breathing circuits after receiving reports that cracks may form in the hose during use. These cracks may cause leaks, potentially resulting in the ventilator or anesthesia device providing inadequate ventilation.

The use of affected products may cause serious adverse health consequences, including low oxygen levels (hypoxia), high carbon dioxide levels (hypercarbia), and death.

Draeger has not reported any serious injuries or deaths related to this issue.

Device Use  

The affected breathing circuits are used in hospitals and clinical settings to deliver breathing gases to patients under anesthesia or during mechanical ventilation.

Contact Information  

Customers in the U.S. with questions about this recall should contact Draeger, Inc. Customer Service at (267) 664-1131.

Additional FDA Resources:  

• FDA’s Enforcement Report  
  • Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355
  • Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software V...
  • Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Num...  
  • Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Numbe...
  • Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Nu...
  • Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Numbe...
• Medical Device Recall Database:
  • Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Versi...
  • Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software V...
  • Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Numbe...
  • Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Num...
  • Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Numbe...
  • Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Nu...
  • Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Numbe...

Unique Device Identifier (UDI)  

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

• How do I recognize a UDI on a label?  
• AccessGUDID database - Identify Your Medical Device  
• Benefits of a UDI System.

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.

Read the full alert.