Puritan Bennett 980 Series Ventilator Recall Due to Assembly Defect
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to an assembly error where a capacitor was incorrectly installed, potentially causing the device to become inoperable during 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 mandates a minimum severity level of 4 (Severe). No reported illnesses, injuries, or deaths prevent a higher rating. The defect involves a critical care device where inoperability during use could pose a serious risk.
Plain-English summary
Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators (model 980X1PLDIPC) due to a manufacturing assembly defect. The device contains a capacitor that may have been assembled incorrectly, which could cause the ventilator to become inoperable during use.
The recalled units were distributed worldwide, including throughout the United States. Affected serial numbers include: 35B1700425, 35B1700438, 35B1700458, 35B1700460, 35B1700656, 35B1700659, and 35B1700660.
This is a Class I recall. Healthcare facilities and providers using affected ventilators should identify units by serial number and follow FDA and manufacturer guidance for corrective action.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980X1PLDIPC
- 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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