Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets

What to Do

Do not use affected product. Identify affected product, cease use and distribution, and return to CooperSurgical.

On August 11, CooperSurgical sent all affected customers a letter recommending the following actions:

• If the loose connection is recognized during the use of the CPAP, replace the tubing with another tubing or CPAP device.
• Stop further use or distribution and segregate affected product
• Notify relevant personnel in your facility who use these devices
• If any products have been forwarded to another facility, contact that facility and provide them with the firm’s notice

Reason for Recall

CooperSurgical stated the units from specific lots of the INCA Neonatal Nasal CPAP Complete Set and Replacement Set may exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use. If the loose connection is not detected during assembly and/or placement, the tubing may leak at the connection to the nasal cannula or disconnect from the nasal cannula. This can result in loss of CPAP pressure, which may reduce the effectiveness of treatment and lead to decreased oxygenation of the patient until connection is restored.

As of August 11, CooperSurgical has reported no serious injuries or deaths associated with this issue.

Device Use

The INCA Infant Nasal CPAP Assembly is a medical device designed to deliver continuous positive airway pressure (CPAP) to newborn and infant patients requiring respiratory support. The system consists of a clear, soft nasal cannula connected to two shapeable “Stay-Flex” tubes that maintain a fixed position to minimize patient movement and nasal trauma. The assembly includes built-in tubing adapters, an in-line pressure adapter, a knit cap with fixation straps, and a chin strap to manage air leaks and secure the circuit.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact CooperSurgical Recall Support Team at [email protected] or 203-895-2789.

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.

Timeline of Communication Updates