In addition to announcing its second-quarter earnings last week, Boston Scientific issued an advisory to doctors regarding three older models of its implantable heart defibrillators (ICDs), according to a company advisory letter. The company has been under scrutiny recently regarding regulatory and product issues.

The models, Contak Renewal 3, Contak Renewal 4 and Vitality HE, were made in 2006 and 2007. About 34,000 are currently implanted in patients, according to Boston Scientific.

The problem is related to a magnetic switch on the devices, which can get stuck, stopping the unit from delivering an electric shock to the hearts of patients, according to the company's letter to doctors.
No patient deaths or injuries have been reported as a result of the glitch, but some devices were replaced, according to the company. The company noted one failure for every 670 devices, but the possibility of patient harm is less than one in one million devices.

The devices are no longer sold, nor are they available in hospital inventories.

Instead of replacing the devices, the company recommends that patients see their doctors for routine follow-up sessions, reported The Wall Street Journal.

The Natick, Mass.-based company, while reporting low numbers for the second quarter, performed better than expected. The company announced net sales of $1.9 billion, compared to $2.1 billion for the second quarter of 2009.

Boston Scientific was hit hard after its ICDs were off the market for a month earlier this year, due to failing to follow protocol detailing that the company had added a new component supplier and reworked a cleaning process for the devices.

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