Reported Jun 3, 2020 · Ongoing
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
Heartware, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 Implant Kit, Product (REF) Number 1104JP
- Lot codes and dates
- GTIN 00888707000697
- Serial numbers
HW34700HW34703HW34710HW34713 GTIN 00888707005838
- Serial Numbers
81 of 81 codes
HW40383HW40412HW40413HW40414HW40415HW40417HW40418HW40419HW40420HW40421HW40422HW40423HW40424HW40425HW40426HW40428HW40429HW40431HW40465HW40471HW40472HW40473HW40474HW40475HW40476HW40477HW40478HW40479HW40480HW40552HW40553HW40554HW40555HW40556HW40557HW40564HW40565HW40580HW40599HW40600HW40602HW40603HW40604HW40607HW40609HW40611HW40612HW40613HW40649HW40650HW40651HW40652HW40653HW40655HW40656HW40657HW40658HW40659HW40660HW40661
- Amount recalled
- 85 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Stop using this product now
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
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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