Guidant Recall Information and Legal Guide
April 12, 2007 Guidant Defibrillator Recalls
Boston Scientific/Guidant and the FDA recalled a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families.
Guidant Recalls New Batch of Pacemakers
Monday, June 26, 2006 -
27,200 Guidant pacemakers and defibrillators recalled due to faulty electronic part.
Guidant Corporation Expands Pacemaker Recall
Tuesday, January 24, 2006 -
Guidant Corp. expanded its recall to include 19,300 pacemaker models that may contain a potentially serious but rare glitch.
Guidant Corporation Alert:
Wednesday, December 14th, 2005 -
The FDA announces that it has received several recent reports about new deaths from heart devices manufactured by Guidant Corporation.
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Recent reports have surfaced about new patient deaths associated with fatal complications from heart devices manufactured by Guidant Corporation.
Each of these new cases occurred after June, when the company was forced to recall the devices after evidence of deadly short circuits emerged.
Agency records show that the Food and Drug Administration has recently received these new reports, which brings the number of known deaths associated with the flaw to seven.
Guidant Corp. had last issued yet another recall on September 22 for almost 170,000 of its top-selling pacemakers, following a two-week federal inspection of its cardiac unit.
With this newest development, Indianapolis-based Guidant has recalled about 200,000 pacemakers because of reported malfunctions - all since June. The company has also recalled or issued warnings about 88,000 heart defibrillators.
The medical device industry was first shaken by Guidant on June 17, 2005, when the company recalled several of its well known and highly distributed ICDs due to their propensity to develop wiring short circuits that can lead to failures of the mechanisms. What was most shocking, however, was that Guidant had known about the failures all along.
Guidant was incorporated in 1994, and quickly reached national and global prominence in the medical supply industry. In the past 11 years Guidant revenue has totaled over 3.8 billion dollars, with 12,000 employees headquartered in such centers of technological innovation as California, Texas, and Washington, with support facilities in Minnesota, Puerto Rico, and Ireland. In 2005, manufacturing giant began proceedings to buy Guidant Corporation for 25 billion dollars, making it one of the most profitable ventures in modern American history.
One of the flagship products that fueled Guidant’s spectacular profits was the Implantable Cardiac Defibrillator. These miraculous devices are a simple computer that monitors irregular heartbeats called arrhythmias in people who have damaged or unhealthy hearts. An arrhythmia can cause a patient to undergo ventricular defibrillation, a deadly condition that can result in sudden cardiac death within a matter of moments. The computer detects a heartbeat that is either too fast ( tachycardia) or too slow (bradycardia), and sends a shock into the heart to return it to a normal rhythm.
These devices saved many lives that were once thought impossible to save. They had flaws, as all machines do, but were considered to be some of the most reliable machines ever created. Unfortunately in 2002 Guidant was notified of a potential problem with the wiring of some of the computers of its Ventak Prizm 2 DR (model 1861) could short circuit due to faulty insulation in some of its wires. Guidant was sure this flaw would be corrected in future models, but only notified doctors of this potential malfunction in May 2005. Furthermore, the Contak Renewal (models H135 and H155) made before 2004 are subject to this flaw as well.
There are still 30,000 people who rely on these models to keep their hearts beating. The failure of Guidant to notify their clients and doctors of fatal flaws in their products is inexcusable. While any device can fail, ones that people stake their lives on should be held to a higher standard of quality. Guidant knew their devices were faulty, but delayed notification hoping that future models would correct any flaws. As of May 30th, 2005, two people have died because of this hope. No more should have to.
Breaking News: Dec 5, 2005. Boston Scientific offers up $25 Billion for Guidant
Boston Scientific Corp. made a bid today to purchase
heart pacemaker manufacturer Guidant Corp. for
an estimated $25 billion, beating out Johnson & Johnson’s
bid by $3 billion.
Guidant’s share price climbed almost 9% in afternoon trading on the New York Stock Exchange. Boston Scientific stock went down more than 2%.
The offer came in after Guidant and Johnson & Johnson renegotiated the previous terms of their deal after Guidant's recall of defective defibrillators and pacemakers this summer. Johnson & Johnson lowered its purchase price by 15% from its initial offer to about $21.5 billion after legal concerns about the recall.
Boston Scientific said combining the two companies would create the world's largest manufacturer of devices for heart problems and vascular disease.
"This transaction provides a unique opportunity to advance our strategy to further diversify and to expand the growth markets we serve," said Boston Scientific Chairman Pete Nicholas in a statement. "Combining the resources of two of the earliest pioneers in the field of interventional medicine promises a continuation of the prolific innovation that has enabled major advances in the treatment of so many diseases."
Terms of the deal offered are that, Boston Scientific would purchase each share of Guidant stock for $36 in cash and an additional $36 in Boston Scientific stock. The $72-a-share offer is 14% greater than Johnson & Johnson's bid.
Guidant stock holders would end up owning about 35% of the combined company. A deal might be finalized by the first quarter of next year pending the boards and stockholders of both companies approving the deal.
Guidant in mid June recalled almost 50,000 defibrillators after malfunctions were reported in at least 45 implanted devices, including two that were suspected in patient deaths.
If the deal goes through Boston Scientific would inherit any and all potential lawsuits on the horizon connected with the pacemakers and defibrillators.