The Recall Desk
SevereFDA (Devices)·Z-0341-2022·Announced 2021-12-15

Puritan Bennett 980 Series Ventilator Recall Due to Manufacturing Defect

Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing error where a capacitor was assembled incorrectly, which may cause the device to become inoperable during use.

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: This is classified as an FDA Class I recall. The FDA's rules establish that Class I recalls never score below 4, as they indicate potential for serious injury or death. Although no injuries or deaths have been reported, the risk that a ventilator may become inoperable during use poses a serious patient safety hazard.

Plain-English summary

The Puritan Bennett 980 Series Ventilator (model 980S3ENDICU) is being recalled by Covidien LLC due to a manufacturing assembly error involving a capacitor. The defect may cause the ventilator to become inoperable during use.

Approximately 278 units have been distributed worldwide, including throughout the United States. The affected units are identified by serial numbers 35B1700406, 35B1700449, 35B1700467, 35B1700469, 35B1700471, 35B1700474, 35B1700481, 35B1700526, and 35B1700558.

Healthcare facilities and individuals using affected ventilators should immediately contact Covidien for guidance on device replacement or repair. Patients dependent on this device should consult with their healthcare provider to ensure alternative respiratory support is available.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980S3ENDICU
Manufacturer
Covidien Llc
Category
Medical Device — Ventilator
Hazard
  • assembly-error
  • device-inoperability

Distribution

Distributed nationwide across the United States.

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