Reported Dec 13, 2023 · Ongoing
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Heartware, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heartware, Inc. · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
- PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Product as published 00888707005364Serial Numbers: HW43366, HW42611, HW43316, HW43247, HW43248, HW42405, HW43276, HW43251, HW43313, HW43322, HW43257, HW43262, HW43258, HW43270, HW43197, HW43157, HW43253, HW42375, HW42400, HW42582, HW43125, HW42083, HW43188, HW43042, HW42610, HW42301, HW43062, HW43219, HW43187, HW42420, HW43054, HW43115, HW43053, HW43116, HW42297, HW43109, HW42267, HW43048, HW42591, HW42439, HW42205, HW43040, HW42438, HW42586, HW42082, HW42585, HW42261, HW42404, HW42573, HW42364, HW42070, HW42202, HW42081, HW42184, HW42179, HW42069, HW42403, HW42176, HW41765 00888707005715Serial Numbers: HW42612, HW42685, HW42614, HW42681, HW42615, HW42618 00888707007139Serial Numbers: HW42372, HW42691, HW42832, HW42713, HW43019, HW43027, HW43015, HW42847, HW42697, HW42963, HW42826, HW42929, HW42934, HW42975, HW42954, HW42845, HW42705, HW42846, HW42925, HW42977, HW42978, HW42839, HW42979, HW42980, HW42982, HW42984, HW42985, HW42986, HW42704, HW42930, HW42972, HW42853, HW42924, HW42935, HW42936, HW42956, HW42957, HW42958, HW42959, HW42945, HW42946, HW42950, HW42951, HW42706, HW42699, HW42701, HW42692, HW42693, HW42694, HW42695, HW42696 00888707007160Serial Numbers: HW43453 00888707009041Serial Numbers: HW43032, HW42484, HW42522, HW43489 00888707009423Serial Numbers: HW43068 00888707009454Serial Numbers: HW43096 00888707009485Serial Numbers: HW42688 00888707009492Serial Numbers: HW42926 - Amount recalled
- 125
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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