Z-2039-2020 Class I Terminated
FDA device recall Z-2039-2020 was initiated by Medtronic Vascular Galway DBA Medtronic Ireland on May 12, 2020 and is designated Class I. Reason for recall: Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) The recall status is terminated (terminated March 10, 2022). Affected quantity: 103 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- May 12, 2020
- Termination Date
- March 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 103 units
Product Description
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Reason for Recall
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Distribution Pattern
US distribution in TX, WI, CA, NY, AL, and MI.
Code Information
UDI: 00763000233815, All Lot Numbers