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

Hazard

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

Details from the source

Reason for recall: Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. Distribution: 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, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Ger Quantity: 659 units Lot/code info: UDI: 00813024011712/Serial Number: MLP-026628 MLP-026733 MLP-026929 MLP-027005 MLP-027322 MLP-027363 MLP-027387 MLP-027390 MLP-027596 MLP-027678 MLP-027879 MLP-028290 MLP-028518 MLP-028665 MLP-028754 MLP-028931 MLP-029026 MLP-029108 MLP-029187 MLP-029304 MLP-029368 MLP-029462 MLP-029473 MLP-029656 MLP-029682 MLP-029686 MLP-029845 MLP-030174 MLP-030180 MLP-030215 MLP-030216 MLP-030844 MLP-030945 MLP-030993 MLP-031350 MLP-031430 MLP-031507 MLP-031529 MLP-031710 MLP-031725 MLP-031780 MLP-032045 MLP-032092 MLP-032194 MLP-032302 MLP-032534 MLP-032794 MLP-032917 MLP-032926 MLP-032952 MLP-033026 MLP-033232 MLP-033394 MLP-033541 MLP-033633 MLP-033799 MLP-033829 MLP-033875 MLP-033905 MLP-033948 MLP-033960 MLP-033981 MLP-034050 MLP-034055 MLP-034059 MLP-034089 MLP-034090 MLP-034098 MLP-034135 MLP-034144 MLP-034184 MLP-034266 MLP-034380 MLP-034582 MLP-034594 MLP-034719 MLP-034721 MLP-034724 MLP-034816 MLP-034821 MLP-034835 MLP-034877 MLP-034879 MLP-034883 MLP-034926 MLP-035031 MLP-035032 MLP-035098 MLP-035148 MLP-035177 MLP-035386 MLP-035387 MLP-035510 MLP-035528 MLP-035588 MLP-035609 MLP-035613 MLP-035691 MLP-035700 MLP-035925 MLP-035931 MLP-036123 MLP-036166 MLP-036173 MLP-036254 MLP-036298 MLP-036367 MLP-036413 MLP-036644 MLP-036749 MLP-036797 MLP-036815 MLP-036831 MLP-036872 MLP-037066 MLP-037152 MLP-037213 MLP-037396 MLP-037436 MLP-037470 MLP-037517 MLP-037702 MLP-037746 MLP-037758 MLP-037792 MLP-037867 MLP-037928 MLP-037939 MLP-037945 MLP-038129 MLP-038147 MLP-038156 MLP-038281 ML

UPC codes

00813024011712

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.