What you should know:
1. The FDA commenced the Class 1 recall May 28 after receiving 92 complaints related to the device’s pump assembly process.
2. Thirty-eight complaints were tied to broken strain relief screws and 54 were related to tears in the outflow graft.
3. Two patient deaths were associated with outflow graft tears, and the other two patients died after interventions to address outflow graft tears.
4. The defects “may cause serious patient harm, including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures and death,” the alert read.
5. Medtronic is not pulling the products from the market, but issued guidance for users to inspect their devices. Medtronic recommends users:
- Review the steps for assembly
- Inspect the outflow graft and strain relief attachments
- Continue standard patient management during and immediately after implantation to look for issues
6. Medtronic has 4,924 HeartWare devices in the U.S.
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