The latest recall was announced April 5, 2007, and concerns some 73,000 Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). This recall comes on the heels of similar recalls in 2006 and 2005.
With 30,000 employees and revenues of $7.8 billion last year, Massachusetts based Boston Scientific is keeping rather quiet about this new recall. Fortunately, the U.S. Food and Drug Administration (FDA) is happy to provide information concerning the situation.
According to the FDA, the latest recall is being blamed on "faulty capacitors" that might cause the batteries in these defibrillators "to deplete sooner than expected."
"As of March 30, 2007, Boston Scientific has confirmed 19 field events with Guidant's devices, mostly related to premature battery depletion," reads an FDA "Questions and Answers" sheet regarding the new recall. "There were no serious injuries or deaths reported."The affected models include: the Contak Renewal 3 HE CRT-Ds (Models H177 and H179); Contak Renewal 3 CRT-Ds (Models H170 and H175); Vitality 2 DR ICDs (T165); Vitality 2 VR ICDs (T175); Vitality AVT ICDs (A155); Vitality DS DR ICDs (T125); and Vitality EL DR ICDs (T135).
This is merely the latest in a series of product mishaps involving Guidant Corporation, of Indianapolis, Indiana. In July 2005, Guidant issued a physician advisory informing doctors about problems with "certain pacemakers" as a company press release put it. This recall impacted nine different pacemaker models built between 1997 and 2000.
"A hermetic sealing component" in some of these devices "may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life," reads the Boston Scientific/Guidant press release.
This "moisture content" was wrecking havoc with the electronic controls of a handful of pacemakers: "As of July 11, 2005, Guidant had received reports that 69 pacemakers may have failed because of the leakage," stated the FDA.
In April 2006, Guidant merged with Boston Scientific. Product problems continued to plague the company, however.
A recall notice was issued June 2006 concerning a series of pacemakers and defibrillators. The problem was a faulty capacitor (the same malfunction that led to the 2007 recall).
"Boston Scientific/Guidant has confirmed five reports of device malfunction among some 27,200 patients worldwide in whom these devices were implanted," reads a FDA statement of July 2006. "One malfunction occurred at the time of implantation. In four cases, the patients needed to have the device replaced. The patients lost consciousness in two of these cases. There are no reported deaths."
Skip forward a year and once again Guidant devices are at the centre of a recall notice.
As with previous recalls, the FDA is at pains to state that most of Guidant's defibrillators and pacemakers will continue to work just fine. A quick check-up with the family physician or a heart specialist is recommended for patients with these products.
Considering Guidant's track record with repeated recalls over the past three years, contacting a lawyer might also be a good idea.