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.
Check against the official notice below — it lists the full affected range.
Abbott is recalling the HeartMate 3 LVAS (Left Ventricular Assist System) Implant Kit due to reports of outflow graft twist occlusions. When the outflow graft becomes occluded, patients will experience a persistent low flow alarm. These occlusions can lead to serious complications including hemodynamic compromise, blood clots, and death.
The recall affects approximately 5,607 devices distributed worldwide, including throughout the United States and multiple countries. Specific affected devices can be identified by their serial numbers beginning with "MLP" (for example, MLP 000976, MLP 000989, and many others listed in the recall). The record does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution -- U.S., including the states of MN, PA, IL, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, OH, NY, GA, VA, FL, OK, MD, ME, SC, IN, LA, OR, WA, AL, CO, IA, KS, KY, UT, DC, and CT; and, the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, Cayman Islands, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Quantity: 5,607 Lot/code info: United States: UDI: 00813024013297, Serial Numbers: MLP 000976, MLP 000989, MLP 000991, MLP 000999, MLP 001002, MLP 002020, MLP 002041, MLP 002048, MLP 002049, MLP 002056, MLP 002057, MLP 002058, MLP 002059, MLP 002066, MLP 002069, MLP 002070, MLP 002071, MLP 002072, MLP 002074, MLP 002075, MLP 002076, MLP 002080, MLP 002082, MLP 002084, MLP 002087, MLP 002088, MLP 002090, MLP 002091, MLP 002093, MLP 002096, MLP 002117, MLP 002118, MLP 002119, MLP 002120, MLP 002121, MLP 002123, MLP 002124, MLP 002125, MLP 002126, MLP 002127, MLP 002128, MLP 002130, MLP 002132, MLP 002133, MLP 002134, MLP 002135, MLP 002136, MLP 002137, MLP 002141, MLP 002144, MLP 002152, MLP 002155, MLP 002156, MLP 002157, MLP 002158, MLP 002159, MLP 002160, MLP 002162, MLP 002163, MLP 002161, MLP 002164, MLP 002165, MLP 002188, MLP 002189, MLP 002191, MLP 002192, MLP 002197, MLP 002198, MLP 002200, MLP 002201, MLP 002203, MLP 002204, MLP 002205, MLP 002206, MLP 002207, MLP 002208, MLP 002209, MLP 002211, MLP 002213, MLP 002214, MLP 002216, MLP 002217, MLP 002218, MLP 002219, MLP 002220, MLP 002221, MLP 002222, MLP 002223, MLP 002224, MLP 002226, MLP 002227, MLP 002228, MLP 002229, MLP 002236, MLP 002237, MLP 002238, MLP 002239, MLP 002240, MLP 002241, MLP 002243, MLP 002244, MLP 002245, MLP 002246, MLP 002247, MLP 002248, MLP 002250, MLP 002251, MLP 002254, MLP 002253, MLP 002255, MLP 002257, MLP 002258, MLP 002259, MLP 002261, MLP 002263, MLP 002264, MLP 002266, MLP 002267, MLP 002268, MLP 002269, MLP 0022
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.