Guidant Device Recall
NEWS:
On April 12 th 2007, Boston Scientific/Guidant and the FDA recalled a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families. This new recall includes about 73,000 implantable cardiac resynchronization therapy defibrillators and cardiac defibrillators due to faulty capacitors. While this recall is similar to the recall of May 2006, this time the failure modes and patient outcomes differ. The capacitors have been causing accelerated battery depletion and reducing the time between the elective replacement indicators and end of life to less than three months.
Guidant Device Recall Attorneys
Guidant is one of the largest manufacturers of medical devices in the world. It makes several types of machines and products designed to restore and protect the lives of people who have hearts damaged by disease, surgery, or age. Their main line of products includes a large number of cardiac devices including implantable cardioverter defibrillators, cardiac resynchronization devices, and angioplasty stents.
Guidant has been in the national spotlight recently due to a series of recalls that the company was forced to make. In one of these, due to a manufacturing defect, Guidant Corp notified doctors of potentially fatal flaws in some of their popular cardiac pacemakers. 28,000 of these devices remain implanted in patients, and Guidant acknowledges 69 of its older pacemakers have failed as of July, 2005 Recalled Guidant brands include Pulsar, Pulsar Max, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II, and Contak TR.
Furthermore, Guidant received notice of three more deaths caused by its implantable cardioverter defibrillators in December 2005. These devices are similar to pacemakers, but they keep the heart from going into a potentially fatal condition called fibrillation. The total number of deaths caused by Guidant defibrillators now stands at seven. Recalled defibrillator brands include
- Prizm 2 DR, Model 1861
- Contak Renewal, Model H135
- Contak Renewal 2, Model H155
- Prizm AVT Vitality AVT Renewal 3
- AVT Renewal 4 AVT
- Contak Renewal 3 and 4
- Renewal 3 and 4 AVT
- Renewal RF
All told, 50,000 devices are affected by this recall.
Guidant also recalled a number of their Vision Stents in October 2003 due to a potentially serious manufacturers defect. The Vision Stent is a wire mesh frame used in angioplasty procedures to ensure proper blood flow through the artery after the balloon deflates.
Unfortunately, problems began to surface about the Vision Stent. Due to a manufacturer’s defect, certain lots of the 3mm Vision Stent could become dislodged during the angioplasty procedure or during the recovery period, which could potentially cause catastrophic cardiovascular problems.
If you or someone you love is a victim of Guidant’s negligence and irresponsibility, you need to consult a defective medical device attorney today. You may be entitled to seek compensation for your pain and suffering, but if you hesitate too long you risk losing out on your opportunity for restitution due to restrictive statute of limitation laws. Contact an experienced defective device attorney today.
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