FDA Medical Device Recalls (openFDA)
Medtronic Vascular Galway DBA Medtronic Ireland: Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
- Recall number
- Z-2039-2020
- Recalling firm
- Medtronic Vascular Galway DBA Medtronic Ireland
- Product
- Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
- Status
- Terminated
- Initiated
- 2020-05-12
- Posted
- 2020-05-27
- Terminated
- 2022-03-10
- Reason
- Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
- 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
- 103 units
- Distribution
- US distribution in TX, WI, CA, NY, AL, and MI.
- Lot, serial or model codes
- UDI: 00763000233815, All Lot Numbers
- 510(k) numbers
- ["K181817"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3002806434
- Firm city
- Galway
- Firm state
- not on file
- Firm country
- Ireland
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