Medtronic Heart Valves Division recalls CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;

Recall date

June 11, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2043-2021

FDA classification

Class II

Brand / firm

Medtronic Heart Valves Division

Sold / distributed

U.S.: AL, AK, AR, AZ, CA, CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Albania, Argentina, Australia, Austria, Belarus, Belgium, Brazil, BULGARIA, Cana…

Why it was recalled

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;