Rosenbaum Faria, LLP, a Manhattan lawfirm set to notify clients of the newest round of recalled heart devices. Guidant's Contak Renewal and Vitality models are affected by the new recall based on accelerated battery depletion.
New York, NY (PRWeb) April 15, 2007 -- Rosenbaum Faria, LLP, a Manhattan lawfirm set to notify clients of the newest round of recalled heart devices. Guidant's Contak Renewal and Vitality models are affected by the new recall based on accelerated battery depletion.
Boston Scientific/Guidant, at the direction of the US FDA, has informed doctors and patients that yet another series of heart defibrillator devices may malfunction causing premature battery depletion an unexpected end of life.
According to the FDA website, the recall includes approximately 73,000 devices in the Contak Renewal 3 & 4 families, as well as Vitality and Vitality 2 models. The faulty capacitors in the devices may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL).
Although patients were advised to simply see their doctors to have their batteries checked, doctors were given a timetable to determine whether their patients' devices were affected by the faulty capacitors. By monitoring their patients every 30-90 days, doctors have been asked to determine when battery EOL will occur.
"Unconscionable!" said Cory Rosenbaum of Rosenbaum Faria, LLP, a Manhattan lawfirm already engaged by victims of the first round of Guidant recalls. "To think Guidant is involved in yet another series of faulty devices is unbelievable. There are going to be people out there who had the previous devices replaced and now have these devices implanted. Some of these people are weakened, stressed, and elderly already. This is about the last thing they need."
The alert affects a wide range of one of the most popularly implanted devices, as did the last recall in May 2006. People who didn't receive their letter, for whatever reason, can read the FDA letter at http://www.fda.gov/medwatch/safety/2007/safety07.htm#icd
Said Sol Kodsi, also of Rosenbaum Faria, LLP, "We'll follow up later today with our existing Guidant clients to be sure they received their notification if they currently have these newer devices. Another faulty device will not be good news for these people. Some have been through several of the other defective devices already."
According to the FDA website, "The affected devices distributed in the US 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). Guidant merged with Boston Scientific in April 2006."
"We'll be watching this round of recalls very closely, monitoring our existing clients, and posting incoming information on our website as it becomes available," said Cory Rosenbaum.
Sources:
http://www.fda.gov/cdrh/news/guidantrecall.html
###
Trackback URL: http://www.prweb.com/pingpr.php/U3F1YS1aZXRhLVpldGEtQ3Jhcy1NYWduLVplcm8=
|
