Recall Z-1774-2018 ยท DSQ Ventricular (Assist) Bypass
Abbott
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.
| Date | May 17, 2018 (initiated Apr 5, 2018) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Customers were notified via an Important Medical Device Advisory letter, dated 04/05/2018, that the firm has received reports of outflow graft twist occlusions in the HeartMate 3 (HM3) Left Ventricular Assist System. As a result, patients whose devices experience this issue will experience a persistent low flow alarm. Outflow graft twist occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death. Physicians managing patients that will be implanted or already implanted with HM3 devices should follow the recommendations provided in the letter. Additi |
| Quantity | 5,607 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.