Puritan Bennett 980 Ventilator Recalled for Battery Overheating Risk
Covidien is recalling Puritan Bennett 980 ventilators due to battery overheating and thermal damage risks that could cause burns or smoke exposure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of burns and bronchospasm from smoke or hazardous materials, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Puritan Bennett 980 (PB980) Ventilator Series manufactured by Covidien LLC. The recall involves 23,329 units distributed worldwide, including 12,956 units in the United States and 10,405 units in other countries.
The recall was initiated due to in-house laboratory observations and customer reports of overheating and/or thermal damage to the battery pack. This defect creates a risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm for patients or healthcare providers.
Affected units are identified by specific serial numbers listed in the FDA recall record Z-0425-2021. Healthcare facilities and users should check their inventory against the provided serial number list and contact the manufacturer or FDA for instructions on corrective actions.
The recalled product
- Product
- Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC 980
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Ventilator
Distribution
Distributed nationwide across the United States.
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