Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
Check against the official notice below — it lists the full affected range.
Heartware, Inc. has recalled 85 units of the Heartware HVAD Pump Implant Kit worldwide. The recalled kits have serial numbers listed under two product codes and may have defects in which the Outflow Graft can tear or the Strain Relief screw can break during pre-implant pump assembly and attachment procedures.
The recall notice does not specify a remedy or corrective action that affected consumers should take.
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: 85 units Lot/code info: GTIN 00888707000697, Serial numbers: HW34700, HW34703, HW34710, HW34713 GTIN 00888707005838, Serial Numbers: HW40383, HW40412, HW40413, HW40414, HW40415, HW40417, HW40418, HW40419, HW40420, HW40421, HW40422, HW40423, HW40424, HW40425, HW40426, HW40428, HW40429, HW40431, HW40465, HW40471, HW40472, HW40473, HW40474, HW40475, HW40476, HW40477, HW40478, HW40479, HW40480, HW40552, HW40553, HW40554, HW40555, HW40556, HW40557, HW40564, HW40565, HW40580, HW40599, HW40600, HW40602, HW40603, HW40604, HW40607, HW40609, HW40611, HW40612, HW40613, HW40649, HW40650, HW40651, HW40652, HW40653, HW40655, HW40656, HW40657, HW40658, HW40659, HW40660, HW40661, HW40662, HW40663, HW40664, HW40666, HW40667, HW40668, HW40789, HW40816, HW40881, HW40950, HW40951, HW40952, HW40953, HW40954, HW40955, HW40956, HW40957, HW40958, HW40960, HW40961, HW41045
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.