Reported Jun 3, 2020 · Ongoing
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
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 1103
- Lot codes and dates
- GTIN 00888707000017
- Serial Numbers
HW26899HW27283HW27893HW28873HW28999HW29422HW29488HW29722HW30166HW30170 GTIN 00888707002639
- Serial Numbers
1,375 of 1,375 codes
HW29525HW30015HW30297HW30477HW31174HW31179HW31181HW31246HW31247HW31250HW31253HW31257HW31266HW31268hw31280HW31281hw31282HW31283HW31313HW31385HW31401HW31497HW31525HW31526HW31530HW31531HW31562HW31567HW31596HW31597HW31601HW31602HW31608HW31609HW31612HW31624HW31626HW31634HW31640HW31641HW31642HW31643HW31644HW31645HW31646HW31647HW31648HW31649HW31651HW31652HW31653HW31655HW31656HW31657HW31658HW31659HW31660HW31661HW31662HW31663
- Serial Numbers
1,229 of 1,229 codes
HW40002HW40004HW40006HW40008HW40009HW40010HW40012HW40013HW40015HW40016HW40017HW40018HW40019HW40021HW40022HW40023HW40024HW40025HW40026HW40028HW40030HW40032HW40033HW40035HW40036HW40037HW40038HW40039HW40041HW40042HW40043HW40044HW40045HW40046HW40047HW40048HW40049HW40050HW40051HW40054HW40055HW40057HW40058HW40059HW40060HW40061HW40062HW40063HW40064HW40065HW40066HW40067HW40068HW40069HW40070HW40071HW40072HW40073HW40074HW40075
- Amount recalled
- 2614 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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