Reported Dec 28, 2022 · Ongoing
HeartWare Model 1102
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 Model 1102
- Lot codes and dates
- Serial Numbers
892 of 892 codes
HW951HW1000HW1001HW1002HW1003HW1006HW1007HW1008HW1010HW1011HW1013HW1017HW1018HW1019HW1026HW1027HW1029HW1030HW1034HW1035HW1037HW1038HW1040HW1044HW1053HW1054HW1055HW1056HW1057HW1058HW1059HW1061HW1062HW1063HW1064HW1065HW1066HW1067HW1068HW1076HW1078HW1093HW1094HW1095HW1096HW1097HW1099HW1100HW1101HW1102HW1103HW1104HW1106HW1107HW1108HW1109HW1110HW1112HW1114HW1115
- Serial Numbers
- Amount recalled
- 892 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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