The Cochran Firm Legal Blog

MicroMed Cardiovascular, the maker of a pediatric heart pump designed by famous surgeon, Michael DeBakey, has received a warning letter from the FDA stating that information has come to light that suggests a child's death related to the heart pump was not reported. By law, MicroMed was required to report any death associated with its device within 30 calendar days that it became aware of the death.

MicroMed officials claim the device was working properly and had nothing to do with the 4-year-old cancer patient’s death. The DeBakey VAD was recommended after the child developed life-threatening heart failure as a result of chemotherapy. MicroMed insists the child died not because of the device but due to complications of chemotherapy and an anticoagulant medication.

While the FDA is not saying the device directly caused the death, it is saying that MicroMed had a legal duty to report the death.

The DeBakey VAD was FDA-approved in 2004 and is implanted in the patient’s chest; the only other device close to its kind is the Berlin Heart, but it is for infants and adolescents and worn outside the body.

If you or a loved one has been harmed by a defective medical device, please contact The Cochran Firm, with offices nationwide, today to schedule a confidential, no-cost consultation.

Labels: main