Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Check against the official notice below — it lists the full affected range.
Heartware, Inc. is recalling the Heartware HVAD Pump Implant Kit (product reference number 1104) distributed worldwide. A total of 2,225 units with specific serial numbers are affected. The recall addresses a hazard in which the Outflow Graft may tear and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
The source document does not specify a remedy or describe what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
Reason for recall: The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. Distribution: Worldwide Distribution Quantity: 2225 Units Lot/code info: GTIN 00888707002028, Serial Numbers: HW28848, hw29011, HW29154, HW29211, HW29248, HW29249, HW29273, HW29329, HW29426, HW29465, HW29472, HW29522, HW29534, HW29548, HW29549, HW29567, HW29588, HW29593, HW29602, HW29612, HW29667, HW29700, HW29786, HW29815, HW29915, HW29928, HW29949, HW30039, HW30082, HW30083, HW30150, HW30153, HW30208, HW30211, HW30226, HW30320, HW30342, HW30358, HW30360, HW30363, HW30378, HW30380, HW30382, HW30390, HW30398, HW30400, HW30402, HW30406, HW30410, HW30430, HW30475, HW30484, HW30494, HW30498, HW30595, HW30596, HW30597, HW30601, HW30604, HW30651, HW30768, HW30769, HW30770, HW30771, HW30814, HW30821, HW30829, HW30863, HW30865, HW30867, HW30871, HW30953, HW30961, HW30962, HW30966, HW30971, HW30972, HW30974, HW31020, HW31076, HW31101, HW31103, HW31104, HW31107, HW31113, HW31115, HW31117, HW31119, HW31128, HW31132, HW31134, HW31192, HW31219, HW31223, HW31232, HW31235, HW31242, HW31244, HW31249, HW31254, HW31255, HW31260, HW31261, HW31262, HW31267, HW31383, HW31387, HW31388, HW31399, HW31409, HW31410, HW31411, HW31412, HW31414, hw31445, HW31446, hw31447, hw31448, hw31449, hw31451, HW31452, hw31453, hw31454, HW31455, HW31456, HW31457, HW31458, HW31541, HW31543, HW31544, HW31545, HW31547, HW31548, HW31549, HW31550, HW31552, HW31559, HW31564, HW31571, HW31573, HW31578, HW31579, HW31686, HW31694, HW31697, HW31731, HW31749, HW31750, HW31777, HW31778, HW31810, HW31819, HW31830, HW31831, HW31832, HW31834, HW31835, HW31836, HW31838, HW31839, HW31840, HW31842, HW318
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.