Thoratec Corp.: HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with

Hazard

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

Details from the source

Reason for recall: Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System. Distribution: Worldwide distribution: U.S.(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, VT, WA, WI, and WV; and O.U.S.(foreign) to countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Island, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Repub Quantity: 22,663 kits Lot/code info: HeartMate 3 LVAS Model Numbers: 1. 105581 (IDE, cannot be implanted without a Left Ventricular Assist Device (LVAD)) 2. 105581US (cannot be implanted without a LVAD) 3. 105581INT (cannot be implanted without a LVAD) 4. 106524 (IDE) 5. 106524US 6. 106524INT UDI-DI codes: HeartMate 3 LVAS: 1. N/A (IDE) 2. 00813024013266 3. 00813024011675 4. N/A (IDE) 5. 00813024013297 6. 00813024011712 Serial Numbers: For Model 106524 US MLP-000991 MLP-002058 MLP-002066 MLP-002069 MLP-002070 MLP-002076 MLP-002117 MLP-002126 MLP-002128 MLP-002133 MLP-002136 MLP-002152 MLP-002158 MLP-002159 MLP-002160 MLP-002164 MLP-002165 MLP-002191 MLP-002192 MLP-002197 MLP-002206 MLP-002208 MLP-002216 MLP-002217 MLP-002239 MLP-002241 MLP-002246 MLP-002251 MLP-002254 MLP-002259 MLP-002263 MLP-002268 MLP-002269 MLP-002278 MLP-002288 MLP-002289 MLP-002291 MLP-002294 MLP-002300 MLP-002304 MLP-002309 MLP-002310 MLP-002316 MLP-002318 MLP-002321 MLP-002324 MLP-002337 MLP-002342 MLP-002347 MLP-002355 MLP-002356 MLP-002361 MLP-002365 MLP-002450 MLP-002455 MLP-002456 MLP-002472 MLP-002475 MLP-002510 MLP-002514 MLP-002518 MLP-002519 MLP-002520 MLP-002530 MLP-002536 MLP-002538 MLP-002539 MLP-002543 MLP-002589 MLP-002597 MLP-002603 MLP-002633 MLP-002643 MLP-002646 MLP-002650 MLP-002654 MLP-002660 MLP-002663 MLP-002666 MLP-002805 MLP-002807 MLP-002808 MLP-002809 MLP-002827 MLP-002828 MLP-002838 MLP-002840 MLP-002842 MLP-002844 MLP-002850 MLP-002858 MLP-002957 MLP-003028 MLP-003033 MLP-003057 MLP-003058 MLP-003068 MLP-003070

UPC codes

00813024013266, 00813024011675, 00813024013297, 00813024011712

Source

Official record: FDA (Device enforcement) ↗

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