Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Brand
Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland
Lot Codes / Batch Numbers
UDI: 00763000233815, All Lot Numbers
Products Sold
UDI: 00763000233815, All Lot Numbers
Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland is recalling Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices int due to Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, IN, MI, NY, TX, WI
Page updated: Jan 10, 2026