Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Cat
Check against the official notice below — it lists the full affected range.
Medtronic Inc. has recalled instructional materials and manuals related to the HeartWare Ventricular Assist Device (HVAD) system due to errors and inconsistencies found in the Instructions for Use, Emergency Responder Guide, and Patient Manual. Approximately 21,118 pieces of product literature were affected, distributed worldwide including throughout the United States and to numerous countries in Europe, Asia, Australia, New Zealand, South Africa, and Turkey. The recall involves specific device model numbers and serial numbers for the HVAD 1104 model.
The source document does not specify a remedy or actions that affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
Reason for recall: Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system. Distribution: Worldwide Distribution: US (nationwide) and OUS to countries of: Australia, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, INDIA, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom Quantity: 21,118 pieces of product literature Lot/code info: Device Model numbers affected: 1104: GTIN 00888707002028, Serial Numbers: HW28848, HW29011, HW29154, HW29199, HW29211, HW29212, HW29219, HW29229, HW29246, HW29248, HW29249, HW29252, HW29265, HW29266, HW29268, HW29271, HW29273, HW29274, HW29276, HW29279, HW29282, HW29283, HW29284, HW29285, HW29286, HW29287, HW29290, HW29293, HW29302, HW29309, HW29310, HW29329, HW29333, HW29387, HW29426, HW29465, HW29472, HW29485, HW29502, HW29503, HW29522, HW29526, HW29532, HW29533, HW29534, HW29535, HW29536, HW29538, HW29539, HW29540, HW29541, HW29542, HW29543, HW29546, HW29547, HW29548, HW29549, HW29551, HW29552, HW29562, HW29567, HW29579, HW29583, HW29586, HW29587, HW29588, HW29589, HW29590, HW29592, HW29593, HW29594, HW29595, HW29600, HW29602, HW29603, HW29604, HW29612, HW29629, HW29635, HW29650, HW29660, HW29661, HW29664, HW29665, HW29666, HW29667, HW29668, HW29669, HW29670, HW29671, HW29672, HW29673, HW29674, HW29675, HW29676, HW29685, HW29686, HW29687, HW29700, HW29701, HW29702, HW29717, HW29727, HW29741, HW29754, HW29755, HW29764, HW29776, HW29780, HW29781, HW29782, HW29784, HW29786, HW29787, HW29788, HW29790, HW29791, HW29798, HW29815, HW29820, HW29825, HW29832, HW29836, HW29850, HW29866, HW29867, HW29873, HW29877, HW29887, HW29894, HW29895, HW29896, HW29900, HW29903, HW29904, HW29909, HW29911, HW29915, HW29922, HW29923, HW29927, HW29928, HW29932, HW29949, HW29965, HW29976, HW29983, HW29990, HW29995, HW30038, HW30039, HW30040, HW30079, HW30080, HW30081, HW30082, HW30083, HW30084, HW30
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.