Reported Dec 28, 2022 · Ongoing
HeartWare HVAD Pump Kit, REF 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?
- HeartWare HVAD Pump Kit, REF MCS1705PU
- Lot codes and dates
- UDI/DI 008887070090441
- Serial Numbers
146 of 146 codes
HW41765HW42068HW42069HW42070HW42071HW42081HW42082HW42083HW42176HW42179HW42184HW42195HW42202HW42205HW42261HW42267HW42297HW42298HW42301HW42364HW42368HW42372HW42375HW42379HW42397HW42400HW42401HW42403HW42404HW42405HW42420HW42438HW42439HW42484HW42499HW42522HW42573HW42581HW42582HW42585HW42586HW42591HW42595HW42596HW42610HW42611HW42612HW42614HW42615HW42618HW42681HW42685HW42691HW42692HW42693HW42694HW42695HW42696HW42697HW42699
- Amount recalled
- 146 units
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
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
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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