FDA (Devices) recall action 87446
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
The agency’s own wording, quoted from the enforcement report.
Heartware, Inc. is recalling Medtronic HVAD Batteries because controller power and data cables may damage controller ports due to wear from misalignment.
Heartware, Inc. is recalling 418 Medtronic HVAD Alarm Adapters because cable misalignment may cause damage to the HVAD Controller ports.
Heartware is recalling Medtronic HVAD Packaged Monitors because worn cables may damage controller ports during insertion.
Heartware, Inc. is recalling Medtronic HVAD Monitor Data Cables because they may damage HVAD Controller ports due to wear from misalignment.
Heartware, Inc. is recalling Medtronic HVAD Controller power and data cables due to a risk of damaging controller ports from cable misalignment.
Heartware is recalling Medtronic HVAD Controllers because power and data cables may damage controller ports due to wear from misalignment.