Z-0346-2022Class I

Puritan Bennett 980 Series Ventilator, 980X1ENDIPC

Name: Z-0346-2022 Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
Creator: Covidien Llc
Published: 2021-11-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-11-04 / Terminated / root cause: manufacturing process

FDA source

Covidien Llc began a recall of Puritan Bennett 980 Series Ventilator, 980X1ENDIPC on 2021-11-04. FDA classified it as Class I and gives the reason as "Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0346-2022
Classification: Class I
Status: Terminated
Initiated: 2021-11-04
Posted: 2021-12-09
Terminated: 2024-07-09
Recalling firm: Medtronic, Inc.
Product: Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Root cause tag: manufacturing process
FDA 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 in commerce: 278 total
Distribution: Worldwide distribution - US Nationwide.
Product codes and lots: GTIN/UDI - 10884521172302 Serial Numbers: 35B1700447 35B1700405

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0346-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0338-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0339-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0340-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0341-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0342-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0343-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0344-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0345-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0346-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0347-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0348-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0349-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0350-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0351-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0352-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0353-2022	Class I	Terminated	Voluntary: Firm initiated	2021-12-15	2021-12-09

Product code CBK

K193056Class IIPuritan Bennett 980 Series Ventilator SystemCovidien, LLC / cleared 2020-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)