FDA recall Z-2039-2020

Medtronic Vascular Galway DBA Medtronic Ireland · Class I · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2020-05-12
Report date
2020-06-03
Termination date
2022-03-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Galway, N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2039-2020