Class 1 Device Recall Medtronic Confida Expandable Sheath

• Date Initiated by Firm: May 12, 2020
• Date Posted: May 27, 2020
• Recall Status: Terminated on March 10, 2022
• Recall Number: Z-2039-2020
• Recall Event ID: 85649
• 510(K)Number: K181817
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
• Code Information: UDI: 00763000233815, All Lot Numbers
• FEI Number: 3002806434
• Recalling Firm/ Manufacturer: Medtronic Vascular Galway DBA Medtronic Ireland; Parkmore Business Park West; Galway Ireland
• For Additional Information Contact: Medtronic Customer Service; 800-854-3570
• Manufacturer Reason for Recall: Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DYB