Zyno Medical Infusion Pump Recall Due to Deadly Risk of Air Embolism

Manufacturer is instructing medical providers to stop using certain Zyno infusion pumps until a new software update is installed, following reports of injury.

Federal health officials have announced a Class I medical device recall for certain Zyno infusion pumps, which contain a software defect that could allow air bubbles to enter patients’ bloodstreams, posing a risk of serious and potentially life-threatening injuries.

The U.S. Food and Drug Administration (FDA) announced the Zyno Medical Infusion Pump recall on October 15, warning healthcare professionals to stop using the recalled models until the devices have received a corrective software update.

The Zyno Medical Z800 Infusion Systems are used under the supervision of health care providers to deliver fluids, nutrients or medications directly into a patient’s bloodstream through a vein (intravenous infusion). However, the manufacturer has become aware of a defect related to the air-in-line software, which may allow larger-than-expacted air bubbles to enter the patient’s bloodstream, potentially increasing the risk of vascular air embolism, irregular heartbeat, heart attack, stroke, seizure or other life-threatening adverse events.

While no deaths have been reported in connection with the recalled Zyno infusion pumps, there have been at least two reported injuries as a result of the defect. The FDA has classified the action as a Class I recall, which is the most serious type, indicating that continued use of the product could lead to serious injury or death.

The Zyno Medical Infusion Pump recall involves the following models and Unique Device Identifier (UDI) numbers, which were distributed to healthcare facilities nationwide:

• Z-800 (00814371020006)
• Z-800W (00814371020020)
• Z-800F (00814371020013)
• Z-800WF (00814371020037)

Zyno Medical LLC first alerted healthcare providers about the software defect in the air-in-line system of certain infusion pumps through an Urgent Medical Device Correction letter on September 13, 2024.

The letter instructed customers to immediately stop using the pumps, and provided directions for returning the devices for a necessary software update. The manufacturer further requested that healthcare professionals notify other users, including those at any locations where the devices may have been relocated.

The letter also asked customers to complete the Zyno Medical Infusion Pump—Air-In-Line Software Issue—Response Verification Form, which includes checking inventory for affected products, verifying serial numbers, confirming product locations, reporting transferred products, and signing and dating the completed form.

A representative from Zyno Medical’s partner company, Intuvie LLC, will contact customers to coordinate instructions for exchanging devices. U.S. customers with questions about the recall can contact their Zyno Medical local business partner or email feedback@intuvie.com.

In addition, customers can report adverse reactions or quality problems to the FDA Safety Information and Adverse Event Reporting Program, MedWatch.