Puritan Bennett 980 Series Ventilator Recall - Capacitor Assembly Error
Covidien is recalling 278 Puritan Bennett 980 Series ventilators (model 980X3ENDIUU) due to a capacitor assembly error that may cause the device to become inoperable during patient use.
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 designates this manufacturing defect in a critical life-support device. No illnesses or injuries have been reported, but the potential for serious patient harm from ventilator failure during use warrants this severity level.
Plain-English summary
Covidien is recalling 278 Puritan Bennett 980 Series ventilators (model 980X3ENDIUU) distributed worldwide and throughout the United States.
A capacitor within affected units was incorrectly assembled during manufacturing. This error may cause the device to become inoperable during use, potentially leaving patients without necessary respiratory support.
Affected units can be identified by serial numbers from 35B1700308 through 35B1703383. Patients and healthcare facilities should immediately stop using any ventilators matching these serial numbers. Contact Covidien for instructions on obtaining a corrected device or replacement.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Ventilator
- 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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