Thoratec Corp. recalls Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

Recall date

March 1, 2024

Source

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

Recall number

Z-1693-2024

FDA classification

Class I

Brand / firm

Thoratec Corp.

Sold / distributed

Worldwide Distribution: US (nationwide): 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 OUS (foreign) countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, C…

Why it was recalled

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly