FDA Medical Device Recalls (openFDA)
Covidien Llc: Puritan Bennett 980 Series Ventilator, 980S3ENDICU
- Recall number
- Z-0341-2022
- Recalling firm
- Covidien Llc
- Product
- Puritan Bennett 980 Series Ventilator, 980S3ENDICU
- Status
- Terminated
- Initiated
- 2021-11-04
- Posted
- 2021-12-09
- Terminated
- 2024-07-09
- Reason
- Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Root cause
- Reprocessing Controls
- Action
- On November 4, 2021, the firm began to notify customers through Urgent Medical Device Correction letters. Customers were informed of the device defect that may lead to the ventilator becoming inoperable during use. Actions you should take Immediately discontinue use of the affected ventilators. Remove the affected ventilators from clinical service and quarantine the affected ventilators until such time that a Medtronic Technical Service Engineer inspects and replaces the affected printed circuit board assemblies. Notify all personnel in all care environments in which the affected PB980 series ventilators are used about this medical device correction. If your facility has distributed affected PB980 series ventilators to other persons or facilities, please promptly forward a copy of this letter to those recipients. Complete the attached form and return it as directed to confirm your receipt and understanding of this information. If you are aware of any incidents related to this issue, please contact our Technical Support Department immediately at 1-800-255-6774, option 4, and then option 1 to provide information regarding those events so regulatory reporting obligations can be fulfilled. Work with the Medtronic Technical Support Department if you require assistance finding alternative ventilation devices. Beginning November 5, 2021, Medtronic Technical Service will contact all affected customers to schedule a service appointment for all potentially affected ventilators. If you have any questions regarding this communication, please contact your Medtronic representative or Technical Service at 1-800-255-6774.
- Quantity
- 278 total
- Distribution
- Worldwide distribution - US Nationwide.
- Lot, serial or model codes
- GTIN/UDI - 10884521171244 Serial Numbers: 35B1700406 35B1700449 35B1700467 35B1700469 35B1700471 35B1700474 35B1700481 35B1700526 35B1700558
- 510(k) numbers
- ["K193056"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28