Heartware International, a medical device manufacturer based in Framingham, Massachusetts, announced that it will be issuing a field correction for its HVAD heart pump. According to a press release by the company, the issue had led to a failure rate of 0.004 percent out of a total of 2,900 implants.

The company stated that the driveline connector in the back of the ventricular assist device could become fully or partially separated after periods of extended use.

In its press release, the company stated, "In the unlikely event of a separation, a repair may be necessary. If left unattended, electrical connection to the controller could be affected and a VAD stop alarm could result. None of the confirmed events have resulted in harm to the patient.” It continued, "In the event of a separation, hand-tightening of the connector housing may be sufficient as a temporary measure.”

According to HeartWare, the company will be making changes in its manufacturing process to minimize the risk of this issue in the future. The company also stated that it doesn’t believe this issue will have a negative impact on its finances. While the United States Food and Drug Administration has not yet issued a recall status for HeartWare, the company believes the issue will place the product in Class I, the highest recall level. The company plans to roll out the manufacturing fix by the 15th of February.

References

www.sec.gov/Archives/edgar/data/1389072/000119312513043789/d482097d8k.htm