Z-2039-2020Class I

Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced...

Name: Z-2039-2020 Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced...
Creator: Medtronic Vascular Galway DBA Medtronic Ireland
Published: 2020-05-12
License: https://open.fda.gov/license/

Medtronic Ireland / initiated 2020-05-12 / Terminated / root cause: manufacturing process

FDA source

Medtronic Vascular Galway DBA Medtronic Ireland began a recall of Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries on 2020-05-12. FDA classified it as Class I and gives the reason as "Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)". 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-2039-2020
Classification: Class I
Status: Terminated
Initiated: 2020-05-12
Posted: 2020-05-27
Terminated: 2022-03-10
Recalling firm: Medtronic Ireland
Product: Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Product code: DYB Introducer, Catheter
Reason for recall: Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall on 05/12/2020 by letter. The notice instructed the consignee to quarantine the product and return it to Medtronic.
Quantity in commerce: 103 units
Distribution: US distribution in TX, WI, CA, NY, AL, and MI.
Product codes and lots: UDI: 00763000233815, All Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2039-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2039-2020	Class I	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-27

Product code DYB

K181817Class IItransGlideXT Expandable IntroducerTransaortic Medical, Inc. / cleared 2019-03-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)