RECALL NEWS & UPDATES

Guidant Put Speed Ahead of Heart-Device Quality, Ex-Worker Says
Bloomberg - January 13, 2006
...Guidant Corp. reduced training and emphasized production speed over quality at its troubled factory making implantable heart devices in St. Paul, Minnesota, according to a 14-year worker who trained others there. Management set "unrealistic" goals for production of pacemakers and defibrillators and offered incentives for meeting them...

New York Attorney General Sues Defibrillator Maker; Spitzer alleges defect in Guidant's life-saving defibrillators
USA Today - November 3, 2005
Guidant (GDT) shares fell Thursday after New York Attorney General Eliot Spitzer accused the company of failing to inform physicians about a potentially fatal mechanical flaw in some of its surgically implanted heart defibrillators.  "We wouldn't permit this type of conduct in connection with the sale of cars or washing machines," Spitzer said. "It is simply unconscionable that it occurred with a critical medical device."

FDA: Defibrillator defects on the rise
CNN - September 16, 2005
Malfunctions in implanted heart defibrillators were on the rise even before this summer's massive recall by Guidant Corp., government and Harvard University scientists reported Friday.  About 20 of every 1,000 defibrillators implanted are malfunctioning, and defects led to 31 deaths between 1990 and 2002, concluded research sponsored by the Food and Drug Administration.

F.D.A. Expanding Inquiry Into Heart-Device Company
New York Times - August 25, 2005
... The Food and Drug Administration said yesterday that it would conduct an extensive inspection of the manufacturing facilities of the Guidant Corporation, a maker of implantable heart devices that is under scrutiny for the way it disclosed product problems.

Implant Recalls Heighten Anxiety
Pittsburgh Post-Gazette - August 21, 2005
... Guidant knew of risks ... But the scrutiny of Guidant and other defibrillator makers may be just getting under way. In May, the New York Times said the Indianapolis corporation sold a defibrillator model it knew had a small risk of malfunctioning, but didn't issue warnings about it for three years.

Guidant braces for legal battle
Minneapolis Star-Tribune - August 16, 2005
... Many of these lawsuits were filed by patients like (Daniel) Flynn who believe the Indianapolis-based company hid important safety information about the devices. Others were filed on behalf of investors who saw the value of their shares decline as the bad news continued to dribble out early this summer.

Patients with defibrillators face tough choice
USA Today - August 11, 2005
... Patients recently learned that their pager-sized ICDs had a rare flaw that could cause them to short-circuit and fail just when they might need them to save their lives.

Problems with heart device raise questions
St. Petersburg Times - August 7, 2005
... A group is debating how soon doctors should be notified when flaws are reported.

Heart implants raise questions as their use soars
International Herald Tribune; New York Times - August 3, 2005
... A little-known heart device, an implantable defibrillator, has been under the spotlight since a recent disclosure that a manufacturer, Guidant, did not tell doctors for years that one of its models had a defect that could render it useless.

Guidant And FDA Could Face Senate Scrutiny
WCCO.COM - July 31, 2005
... Sen. Charles Grassley, R-Iowa, chairman of the Senate Finance Committee, asked the FDA to provide documents relating to Guidant's series of recalls.

New Report of Problems at Guidant
New York Times - July 30, 2005
... A filing, which was first publicly disclosed earlier this month, shows that a heart patient implanted with a specific type of Guidant unit "presented to a hospital" around the beginning of March after suffering cardiac arrest, an often fatal condition that the device known as a defibrillator is intended to prevent. This happened two weeks before a college student with a flawed heart device died in March.

As Many As 69 Pacemaker Models May Have Failed; Two Deaths and Dozens of Product Failures Led to Recalls
Consumer Reports - July 26, 2005
... On July 22, the Food and Drug Administration classified Guidant's recall as Class I, the most serious kind. As many as 69 pacemakers may have failed according to Guidant. All the reported failures occurred in devices that had been implanted in patients for at least 44 months.

Guidant adds five additional defibrillators to warning
SunHerald.com - July 24, 2005
... A second safety warning from Guidant Corp., one of the nation's largest medical device manufacturers, urged doctors to stop using five defibrillator models because they could malfunction and may have to be recalled. Indianapolis-based Guidant announced its second worldwide safety advisory in a week on Friday, after voluntarily recalling seven defibrillator models last week. The pager-sized devices sense an irregular heart rhythm and shock the heart back into correct beating. At least 74,900 defibrillators are now under a company warning.

The warnings include the Contak Renewal 3 model, the company's largest seller, and Contak Renewal 4, as well as the Renewal RF. It also covers the Renewal 3 and the Renewal 4 AVT models.

Guidant's Defibrillator 'Fix' May Raise Other Risks
Indianapolis Star - July 23, 2005
The Guidant Corporation said Friday that one of its recent recommendations for correcting problems with some of its defibrillators might actually increase the risk of malfunction in three models implanted in about 21,000 heart patients. The company said a programming change that it suggested to doctors in June might "significantly increase" the risk that a magnetic switch in the Ventak Prizm, Vitality and Contak Renewal devices would become stuck and prevent them from providing treatment.

UPDATE 2-Guidant revises recommendations on ICD fix
Reuters - July 22, 2005
... CHICAGO, July 22  - Guidant Corp. on Friday revised its recommendations about how to handle problems with some of its recalled implantable heart devices because of increased risk to patients.

F DA Announces Guidant’s Class I Pacemaker Recall
U.S. Food & Drug Administration Website - July 22, 2005
... The U.S. Food and Drug Administration (FDA) is notifying health care providers and patients that Guidant Corporation is voluntarily recalling certain pacemakers. A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.

Only the following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000.

• PULSAR® MAX Models 1170, 1171, 1270
• PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
• DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
• MERIDIAN® Models 0476, 0976, 1176, 1276
• PULSAR MAX II Models 1180, 1181, 1280
• DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
• CONTAK TR® Model 1241
• VIRTUS PLUS® II* Models 1380, 1480
• INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

* VIRTUS PLUS II and INTELIS II models available only outside the U.S.

Guidant adds to heart-device alerts; 28,000 patients effected
USA Today - July 19, 2005
....The nine types of pacemakers, which correct irregular heartbeats, may fail suddenly or cause a high rate for too long, Guidant says. It said a sealing component can degrade, allowing body fluids into the device.

Update 6: Guidant Warns on 28,000 Pacemakers
Forbes - July 18, 2005
... Guidant Corp., already under fire for problems with its implantable defibrillators, on Monday warned physicians replacements might be needed for nine pacemaker models made between 1997 and 2000.