Boston Scientific is one of the biggest medical device manufacturers and is a market leader in intervention cardiology products like stents. In March 2010 timeframe Boston Scientific recalled its defibrillators (ICD) from market, due to couple of manufacturing changes that were not reported to FDA. Boston Scientific took necessary steps and got clearance from FDA within two months of recall. FDA praised Boston Scientifics’ voluntary recall and its proactive approach, although patients were not at risk at any stage.
Cardiac Rhythm Management, CRM business of Boston Scientific has not fully recovered from the voluntary recall and another problem knocks at door of Boston Scientifics’ implantable defibrillators. Three brands of defibrillators, namely Contak Renewal 3, Contak Renewal 4 and Vitality HE ICDs that were manufactured in 2006 and 2007 were reported to have problems. These defibrillators were estimated to be implanted in about 34, 000 patients.
What was the main problem?
Boston Scientific acknowledged that:
- a magnetic switch on implantable defibrillators can get stuck
- as a result, device may not deliver electric shock to patients, who need therapy
- the intended function of switch is to prevent from delivering shock, when doctor is doing a medical procedure on patient...
by a magnet.
- the switch should open and resume device normal function, when magnet is removed
Are there any injuries reported due to malfunction?
According to Boston Scientific it has not received any reports of death or injuries. Although some doctors have removed defective devices from patients, Boston Scientific recommended against this practice.
Boston Scientific said that doctors can reprogram the defibrillators to correct the problem. Boston Scientific has faced many problems with its CRM division, which was acquired after it bought Guidant. The company has been struggling to keep its stock from going down and recalls on top of that leads to loss of reputation and revenue.
I hope that Boston Scientific is able to bounce bank and regain the confidence of its customers and physicians.