HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Check against the official notice below — it lists the full affected range.
HeartWare, Inc. has recalled 19,616 batteries (Product Number 1650DE) used in the HeartWare Ventricular Assist Device (HVAD) System due to battery performance issues. The affected batteries may fail to power the controller, refuse to accept a charge from the battery charger, and/or may appear fully charged while actually discharging. The batteries were distributed worldwide, including across the United States and numerous countries in Europe, Asia, the Middle East, Africa, Australia, and South America. The recall affects specific serial numbers listed in the official record.
The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Reason for recall: Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging. Distribution: Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, Estonia, Lebanon, Croatia, Spain, Austria, United Arab Emirates, Luxembourg, Canada, Korea, Republic Of, Israel, Qatar, India, Australia, New Zealand, Taiwan, Mal Quantity: 19616 batteries Lot/code info: a. GTIN 00763000187767, Serial Numbers: BAT941874, BAT941880, BAT941886, BAT941935, BAT941937, BAT941944, BAT941948, BAT941960, BAT942348, BAT941747, BAT941897, BAT941955, BAT941959, BAT937852, BAT937853, BAT937887, BAT937889, BAT937893, BAT941119, BAT941132, BAT941148, BAT941962, BAT941976, BAT941988, BAT942254, BAT937888, BAT937890, BAT941133, BAT941145, BAT941147, BAT941149, BAT941303, BAT941963, BAT941965, BAT940874, BAT941024, BAT942202, BAT942217, BAT942241, BAT942270, BAT942272, BAT942199, BAT942203, BAT942212, BAT942214, BAT942218, BAT942222, BAT942224, BAT942242, BAT942248, BAT942267, BAT942271, BAT942273, BAT942311, BAT942329, BAT939092, BAT939174, BAT939176, BAT939178, BAT941257, BAT941259, BAT941263, BAT939173, BAT939175, BAT939177, BAT940999, BAT941262, BAT942204, BAT942206, BAT942236, BAT942240, BAT939078, BAT939086, BAT939088, BAT942256, BAT942262, BAT942264, BAT942266, BAT939075, BAT939079, BAT939085, BAT942261, BAT942265, BAT817284, BAT817286, BAT817290, BAT817295, BAT901435, BAT937553, BAT937555, BAT937557, BAT817283, BAT817285, BAT817287, BAT817296, BAT901437, BAT905645, BAT937554, BAT937556, BAT817154, BAT941249, BAT817279, BAT942010, BAT942016, BAT942024, BAT942038, BAT941240, BAT942009, BAT942017, BAT810945, BAT813071, BAT813185, BAT813193, BAT815482, BAT815484, BAT815500, BAT817472, BAT817474, BAT817476, BAT817520, BAT817522, BAT905562, BAT905566, BAT905587, BAT905591, BAT906809, BAT932077, BAT932081, BAT932083, BAT937773, BAT937895, BAT937898, BAT93911
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.