Medtronic is recalling its HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief as the outflow graft of the HVAD Pump may tear and the strain relief screw may break during assembly prior to implant, according to a statement from the Food & Drug Administration.
- FDA identifies this as a Class I recall, the most serious type of recall
- Use of products may cause serious patient harm including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures and death
- Medtronic has received 92 complaints related to the pre-implant pump assembly process
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