HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom sub
Check against the official notice below — it lists the full affected range.
Heartware, Inc. is recalling 5,489 HeartWare HVAD System Battery Chargers due to a potential safety hazard where users could mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. The HVAD System is a device that provides heart support for patients with advanced heart failure. The recalled chargers were distributed internationally to countries including Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, and others, but no affected devices were distributed within the United States.
The recalled Battery Chargers include Model Number 1610 with all serial numbers, with specific lot codes ranging from BCH000001 through BCH000042 and beyond. The record does not specify what remedy consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Reason for recall: Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. Distribution: No affected devices distributed within the US. International distribution to Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, EGYPT, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Korea, Korea, Republic of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Netherlands, New Zealand, Nor Quantity: 5,489 devices total Lot/code info: Model Number: 1610, all Serial Numbers. Known Model Numbers (Serial Numbers) GTIN Numbers: 1610GB (BCH000001) 00888707002219, 1610GB (BCH000002) 00888707002219, 1610DE (BCH000003) 00888707002202, 1610DE (BCH000004) 00888707002202, 1610IT (BCH000005) 00888707002240, 1610IT (BCH000006) 00888707002240, 1610DE (BCH000007) 00888707002202, 1610DE (BCH000008) 00888707002202, 1610CH (BCH000010) 00888707002196, 1610DE (BCH000011) 00888707002202, 1610DE (BCH000012) 00888707002202, 1610CH (BCH000013) 00888707002196, 1610IT (BCH000014) 00888707002240, 1610DE (BCH000015) 00888707002202, 1610DE (BCH000017) 00888707002202, 1610DE (BCH000018) 00888707002202, 1610DE (BCH000019) 00888707002202, 1610IT (BCH000020) 00888707002240, 1610DE (BCH000021) 00888707002202, 1610GB (BCH000022) 00888707002219, 1610GB (BCH000023) 00888707002219, 1610DE (BCH000024) 00888707002202, 1610IT (BCH000025) 00888707002240, 1610IT (BCH000026) 00888707002240, 1610IT (BCH000027) 00888707002240, 1610DE (BCH000028) 00888707002202, 1610CH (BCH000029) 00888707002196, 1610CH (BCH000030) 00888707002196, 1610DE (BCH000031) 00888707002202, 1610DE (BCH000032) 00888707002202, 1610DE (BCH000033) 00888707002202, 1610DE (BCH000034) 00888707002202, 1610GB (BCH000035) 00888707002219, 1610DE (BCH000036) 00888707002202, 1610GB (BCH000037) 00888707002219, 1610CH (BCH000038) 00888707002196, 1610CH (BCH000039) 00888707002196, 1610DE (BCH000040) 00888707002202, 1610GB (BCH000041) 00888707002219, 1610CH (BCH000042) 00888707002196, 1610GB (B
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.