Not quite, actually. But the pacemakers and defibrillators of medical device company Guidant aren’t exactly inspiring the confidence of the influential “bad ticker” set.
The Food and Drug Administration has warned Guidant that, in the agency’s opinion, it has not resolved the manufacturing problems detected in an earlier inspection. In a letter to the company, the FDA said that would likely result in restrictions on its ability to bring new heart devices to the market…
Guidant was plagued throughout 2005 by problems with its cardiac defibrillator.
In June Guidant recalled 88,000 defibrillators and 28,000 pacemakers because of potential problems. The company blamed the recalls on “small, residual imperfections.” The FDA ordered the recalls because of a faulty switch. The electronic devices are supposed to deliver a shock to the heart when they detect an arrythmia.
I can’t even imagine the logistical nightmare of recalling installed pacemakers.