Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Thoratec HeartMate 3 LVAS Implant Kit Recalled by Abbott Due to Reports of outflow graft twist occlusions. Patients whose...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott directly.
Affected Products
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
Quantity: 5,607
Why Was This Recalled?
Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.
Where Was This Sold?
This product was distributed to 35 states: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, DC
About Abbott
Abbott has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report