Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 19,562 units of Heartware HVAD Pump Implant Kits distributed worldwide, including throughout the United States. The recalled pumps were manufactured with impellers from specific supplier lots and are failing to start initially, restart, or are experiencing delays in restart attempts at rates significantly higher than the general pump population. The affected models include PUMP 1103, PUMP 1104, PUMP 1104JP, PUMP 1100, Model 1101, Model 1102, Model 1104CA-CLIN, Model 1205, and Model MCS, with specific serial numbers listed for Model 1103 (and additional serial numbers for other models not fully detailed in the provided text).
The source document does not specify a remedy or recommended course of action for consumers with affected devices.
Written by software from the official notice below. Not reviewed by a lawyer.
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.
Reason for recall: Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population. Distribution: Worldwide - US Nationwide Quantity: 19,562 units Lot/code info: a. Model Number 1103: GTIN 00888707003261, Serial Numbers HW40002, HW40004, HW40006, HW40009, HW40017, HW40025, HW40045, HW40046, HW40048, HW40049, HW40051, HW40054, HW40061, HW40067, HW40068, HW40073, HW40074, HW40075, HW40079, HW40085, HW40087, HW40089, HW40090, HW40094, HW40097, HW40099, HW40100, HW40109, HW40112, HW40120, HW40121, HW40122, HW40138, HW40139, HW40143, HW40145, HW40147, HW40149, HW40152, HW40153, HW40154, HW40157, HW40166, HW40168, HW40169, HW40176, HW40177, HW40178, HW40186, HW40189, HW40190, HW40192, HW40197, HW40199, HW40200, HW40201, HW40202, HW40206, HW40209, HW40210, HW40211, HW40212, HW40223, HW40226, HW40230, HW40232, HW40238, HW40240, HW40245, HW40247, HW40259, HW40262, HW40263, HW40270, HW40271, HW40272, HW40273, HW40281, HW40283, HW40288, HW40292, HW40293, HW40294, HW40295, HW40298, HW40299, HW40301, HW40302, HW40303, HW40305, HW40307, HW40317, HW40322, HW40324, HW40326, HW40329, HW40334, HW40337, HW40340, HW40359, HW40371, HW40373, HW40376, HW40381, HW40384, HW40390, HW40392, HW40395, HW40397, HW40399, HW40402, HW40405, HW40433, HW40436, HW40440, HW40443, HW40444, HW40445, HW40448, HW40453, HW40455, HW40460, HW40466, HW40481, HW40482, HW40483, HW40488, HW40489, HW40490, HW40491, HW40499, HW40501, HW40503, HW40504, HW40509, HW40510, HW40512, HW40515, HW40517, HW40518, HW40520, HW40523, HW40524, HW40527, HW40528, HW40529, HW40530, HW40533, HW40534, HW40537, HW40546, HW40558, HW40567, HW40568, HW40569, HW40572, HW40576, HW40583, HW40585, HW40590, HW
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.