Recall Z-1301-2024 ยท DSQ Ventricular (Assist) Bypass
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 Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventri
| Date | Mar 22, 2024 (initiated Feb 19, 2024) |
| Status | Open, Classified |
| Reason | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System. |
| Root cause | Material/Component Contamination |
| Action | On 02/19/2024, the firm will hand deliver an "URGENT MEDICAL DEVICE CORRECTION" Letter to customers that informs them of Abbott's planned update to Instructions for Use associated with observations of outflow graft deformation known as "Extrinsic Outflow Graft Obstruction" (EOGO) associated with the HeartMate 3 and HeartMate II Left Ventricular Assist Systems (LVAS) which may manifest clinically as a persistent low flow alarm under certain circumstances in some patients and may impair the ability of the LVAS to provide adequate hemodynamic support. Guidance and Recommendations: Continue to pay |
| Quantity | 22,663 kits |
| 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, Belgi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.