Recall Z-0582-2019 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage lef
| Date | Nov 19, 2018 |
| Status | Terminated |
| Reason | HVAD Battery Charger units manufactured with wrong inductors. |
| Root cause | Other |
| Action | On November 2018 Medtronic sent the following letter to all their consignees: Dear Physician or Healthcare Professional: HeartWare, now a part of Medtronic, has been notified by an outside vendor that a quantity of HVAD battery charger units (see image above) may have been manufactured with an incorrect circuit component. This subset may exhibit one or more of the battery charging bays not fully charging the battery and/or battery charger indicators (LED) not lighting. The behaviors may occur in any individual bay, independent of the other charging bays. In analyzed units, up to 2 charging b |
| Quantity | 2031 |
| Distribution | Worldwide distribution - US nationwide distribution in the state of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI. Countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, Fin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.