CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report
Pump MCS1705PU Hvad (HeartWare Ventricular Assist Device) recalled
Heartware is recalling Pump MCS1705PU Hvad (HeartWare Ventricular Assist Device) Implant Kit US. The recall was initiated on 31 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0483-2024
- FDA event ID
- 93405
- Recalling firm
- Heartware, Miami Lakes, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Oct 2023
- FDA classified
- 1 Dec 2023
- Reported
- 13 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 31 Oct 2023 | Recall initiated by company | |
| 1 Dec 2023 | Classified by FDA | +31 days |
| 13 Dec 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Where it was distributed
Worldwide
Questions about this recall
Why was it 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
Which lots are affected?
GTIN 00888707005364, Serial 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; GTIN 00888707005715, Serial Numbers: HW42612, HW42685, HW42614, HW42681, HW42615, HW42618; GTIN 00888707007139, Serial 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; GTIN 00888707007160, Serial Numbers: HW43453; GTIN 00888707009041, Serial Numbers: HW43032, HW42484, HW42522, HW43489; GTIN 00888707009423, Serial Numbers: HW43068; GTIN 00888707009454, Serial Numbers: HW43096; GTIN 00888707009485, Serial Numbers: HW42688; GTIN 00888707009492, Serial Numbers: HW42926
Where was it sold?
Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 93405This product is part of a recall event; the main page for the event is Hvad (HeartWare Ventricular Assist Device) Sterile Implant recalled.
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