DJO VenaFlow Elite Compression Pump Recalled for Battery Fire Risk
DJO, LLC is recalling VenaFlow Elite 30B-B and 30BI-B compression pumps due to a potential battery leakage issue that could cause a fire.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a potential fire hazard (thermal meltdown) in a medical device, which meets the rubric criteria for 'Severe' due to the risk of significant injury or property damage.
Plain-English summary
DJO, LLC is recalling the VenaFlow Elite 30B-B and 30BI-B compression pumps. These devices are used for the prevention of Deep Vein Thrombosis. The recall involves 2,491 units distributed worldwide, including in the United States and numerous international markets.
The recall was initiated because DJO, LLC identified a product safety issue with the battery assembly. There is a potential for battery leakage, which could result in a thermal meltdown or fire.
Consumers who have these specific model numbers should stop using the devices and contact DJO, LLC for instructions on how to proceed with the recall.
The recalled product
- Product
- VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
- Manufacturer
- DJO, LLC
- Hazard
- Affected units
- 2,491
Distribution
Distributed nationwide across the United States.
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