Over the last few years defibrillators and pacemakers have been the subject of several news provoking recalls. Defibrillators and pacemakers are known as implantable cardiac defibrillators or ICDs. ICDs are electronic devices that constantly monitor your heart rate and rhythm. When it detects a very fast, abnormal heart rhythm, it delivers energy to the heart muscle. This causes the heart to beat in a normal rhythm again.
The failure of an ICD to provide the necessary energy to the heart can result in serious injury or death. Thousands of Americans rely on these devices to literally keep them alive. Defibrillator patients are obviously concerned about the frequency of recalls.
In June 2005, Guidant Corp. issued a series of recalls for many of their implantable pacemaker models. Throughout 2005 and 2006 Guidant recalled 22 different models:
· Contak Renewal
· Contak Renewal 2
· Contak Renewal 3
· Contak Renewal 3 AVT
· Contak Renewal 4
· Contak Renewal 4 AVT
· Contak TR
· Discovery
· Discovery II
· Insignia
· Intelis II
· Meridian
· Nexus
· Pulsar
· Pulsar Max II
· Renewal 3 AVT
· Renewal 4 AVT
· Renewal RF
· Ventak Prizm 2 DR
· Ventak Prizm AVT
· Virtus Plus II
· Vitality AVT
Guidant wasn't the only ICD manufacturer that had problems with their defibrillators. On February 3, 2005, Medtronic announced the recall of several models of ICDs because of battery problems which could cause them to fail. The recall involved Medtronic's Marquis line of ICDs, which included the following models:
· Micro Jewel II Model 7223Cx
· GEM DR Model 7271 ICDs
· 7230 Marquis VR
· 7274 Marquis DR
· 7232 Maximo VR
· 7278 Maximo DR
· 7277 InSync Marquis
· 7289 InSync II Marquis
· 7279 InSync III Marquis
In December 2007, Medtronic Corp announced that it agreed to settle 2,682 legal cases related to these recalled defibrillators for $114 million. $95.6 million plus $18.5 million The settlement came after Medtronic's attempt to have the lawsuits dismissed failed in November 2006, when a U.S. district court denied its request.
Medtronic recalled its Sprint Fidelis leads in October 2007. The leads can fracture and cause a defibrillator or pacemaker to issue unnecessary shocks. The lead of a defibrillator is what connects the defibrillator or pacemaker to the heart. The follwing models are affected:
· Sprint Fidelis 6930
· Sprint Fidelis 6931
· Sprint Fidelis 6948
· Sprint Fidelis 6949
Medtronic has said that most patients will not need to have their leads replaced. The company believes that reprogramming devices for most patients will alleviate the increased risk posed by defective leads. Many patients with Sprint Fidelis leads remain very worried; these patients would prefer undergoing lead replacement surgery to have peace of mind.
The ICD market is already huge and quickly growing. The ICD market is so profitable that a bidding war for Guidant emerged even though the company clearly had problems. even after the company recalled thousands of their devices. Despite Guidant's problem Boston Scientific and Johnson & Johnson still competed aggressively to purchase the company. Boston Scientific bought Guidant for $25 billion.