FDA (Devices) recall action 85397
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Heartware, Inc. is recalling HVAD Pump Outflow Grafts because the graft may tear or the strain relief screw may break during pre-implant assembly.
Heartware, Inc. is recalling HVAD Pump Implant accessories due to potential tears in the outflow graft and breakage of the strain relief screw during assembly.
Heartware, Inc. is recalling 85 HVAD Pump Implant Kits because the outflow graft may tear or the strain relief screw may break during assembly.
Heartware, Inc. is recalling 2,225 HVAD Pump Implant Kits because the outflow graft may tear and the strain relief screw may break during pre-implant assembly.
Heartware, Inc. is recalling 2,614 HVAD Pump Implant Kits because the outflow graft may tear and the strain relief screw may break during pre-implant assembly.