Atrium Pneumostat Chest Drain Valve Recalled Following Fatal Preterm Infant Case
Atrium Medical Corporation is recalling 92,430 units of its Pneumostat Chest Drain Valve after a preterm infant died during treatment with the device. The company is revising product labeling and warnings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source reports a death: a preterm infant died following treatment with this device. Per the FDA severity rubric, reported deaths result in a Critical (5) classification regardless of other factors.
Plain-English summary
Atrium Medical Corporation is recalling the Pneumostat Chest Drain Valve, Part Number 16100. Approximately 92,430 units have been distributed domestically throughout the United States and internationally worldwide.
The recall was initiated after the device was involved in the treatment of a preterm infant who died. In response, Atrium Medical Corporation is revising the device's Indication for Use, Contraindications, Warnings, and Precautions.
The recall affects multiple product lots as documented in the FDA safety notice Z-2592-2021.
The recalled product
- Product
- Atrium Pneumostat Chest Drain Valve, Part Number 16100
- Manufacturer
- Atrium Medical Corporation
- Affected units
- 92,430
Distribution
Distributed nationwide across the United States.
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