Medtronic Vascular Galway DBA Medtronic Ireland: Medical Device Recall in 2020 - (Recall #: Z-2039-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.

Product Classification:

Class I

Date Initiated: May 12, 2020

Date Posted: June 3, 2020

Recall Number: Z-2039-2020

Event ID: 85649

Reason for Recall:

Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)

Status: Terminated

Product Quantity: 103 units

Code Information:

UDI: 00763000233815, All Lot Numbers

Distribution Pattern:

US distribution in TX, WI, CA, NY, AL, and MI.

Voluntary or Mandated:

Voluntary: Firm initiated