Thoratec Corp. recalls Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

Recall date

August 7, 2023

Source

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

Recall number

Z-2658-2023

FDA classification

Class II

Brand / firm

Thoratec Corp.

Sold / distributed

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Ca…

Why it was recalled

Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.

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

What was recalled

Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050