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PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP

FDA Recall #Z-0481-2024 — Class II — October 31, 2023

Recall #Z-0481-2024 Date: October 31, 2023 Classification: Class II Status: Ongoing

Product Description

PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP

Reason for Recall

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Recalling Firm

Heartware, Inc. — Miami Lakes, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

126 units

Distribution

Worldwide

Code Information

GTIN none, Serial Numbers: HW25172, HW25169FSCA, HW25170FSCA, HW25174FSCA; GTIN 00763000170967, Serial numbers: HW42722, HW42771, HW42285, HW41696, HW41675, HW40953, HW41848, HW41847, HW41316, HW41828, HW41824, HW41803, HW41670, HW41271, HW41701, HW41674, HW41791, HW41792, HW41804, HW41252, HW41256, HW41700, HW41699, HW41783, HW41317, HW41309, HW41673, HW41254, HW40651, HW40665, HW40663, HW41672, HW41308, HW41269, HW41544, HW41270, HW41214, HW41314, HW40417, HW41263, HW41264, HW41265, HW41047, HW41260, HW41266, HW41251, HW41259, HW41258, HW40579, HW41048, HW41262, HW41045, HW40961, HW40958, HW40956, HW41050, HW41255, HW40881, HW40789, HW40957, HW40960, HW40951, HW40659, HW40602, HW40816, HW40954, HW40950, HW40662, HW40664, HW40580, HW40668, HW40613, HW40652, HW40666, HW40667, HW40660, HW40658, HW40612, HW40420, HW40657, HW40607, HW40552, HW40609, HW40599, HW40424, HW40423, HW40426, HW40600, HW40465, HW40553, HW40554, HW40383, HW40603, HW40653, HW40655, HW40656, HW40473, HW40555, HW40472, HW40422, HW40480, HW40564, HW40565, HW40413, HW40479, HW40557, HW40415, HW40476, HW40478, HW40428, HW40429, HW40477, HW40419, HW40421, HW40425, HW40431, HW40471, HW40474, HW40475, HW40412, HW40414, HW40418

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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