Puritan Bennett 980 Series Ventilator Recalled for Assembly Error Risk
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor that may cause the device to become inoperable during use. This recall affects units worldwide and in the US.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA Class I classification requires a minimum severity score of Severe. The device failure mode—potential inoperability during clinical use of a critical life-support device—poses direct risk to patient safety.
Plain-English summary
Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators (model 980X2ESDIEC) due to a manufacturing assembly error involving a capacitor. The capacitor was assembled incorrectly during manufacturing, which may cause the ventilator to become inoperable during use.
The affected units have serial numbers 35B1700627, 35B1700628, 35B1700629, 35B1700630, 35B1700631, and 35B1700632. These devices were distributed worldwide and throughout the United States.
If you are using an affected ventilator, verify the serial number against the list provided. If your device matches, contact Covidien immediately to arrange replacement or repair. Healthcare providers should discontinue use of affected units and follow up with Covidien on resolution options.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
- Manufacturer
- Covidien Llc
- Affected units
- 278
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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