How Do You Recall Heart Devices? (THOR)

Back on March 19 the FDA recall site noted, “The reported incidence of the defect, disconnected outflow graft bend relief, is 0.91% (29/3,200). Of these 29 incidents, 24 were observed in x-ray images or during surgical procedures, and were thus unlikely to be related to patient symptoms. However, in at least one reported case, it is noted that the disconnected bend relief may have contributed to the need for reoperation. The bend relief is designed to prevent kinking of the outflow conduit that connects the HeartMate II pump to the ascending aorta.”

The FDA also noted in mid-March that the disconnection of the bend relief from the outflow graft might cause one or more of the following symptoms:

• low pump flow, hemolysis,
• fluctuations in pump flow,
• speed and/or power,
• or worsening symptoms of heart failure.

The rates of incident were very low, but some fatalities at the time were reported.  Unfortunately, recalling heart devices is no easy measure and the product was said to have been sent to 226 hospitals throughout the United States, Europe, Canada and other countries.

Thoratech shares had been down as much as 10% but the stock is now down “only” 5.6% at $32.42 on about six-times normal trading volume.

Dear Patient, We need to borrow you to get at your heart again….

JON C. OGG