Guidant Defibrillator and Pacemaker Recall Timeline

The following is a summary of key events in the Guidant device recalls and warnings.

May 23, 2005 - Guidant Issues Safety Advisory Concerning Defibrillator
Guidant issues a safety advisory about certain models of its heart defibrillator, reportedly after the company learned an article by the New York Times was being prepared claiming that Guidant did not tell doctors or patients for three years that the device contains a flaw.

June 1, 2005 - Lieff Cabraser Files Lawsuit Against Guidant
Lieff Cabraser files a lawsuit against Guidant Corporation in federal court in Indianapolis, Indiana, on behalf of a proposed nationwide class of patients implanted with the Guidant Ventak Prizm defibrillator. This was the first lawsuit filed against Guidant based on its faulty defibrillator. The complaint alleges that Guidant misrepresented the safety of its defibrillator, which is subject to short circuiting and malfunctioning.

Guidant - Pacemaker Defects
Information on Guidant pacemakers, defects & lawsuits

Guidant Heart Devices Timeline
Chronological information on defects and lawsuits relating to Guidant heart devices

FDA Warning Information on Guidant Heart Devices
Warning letters and doctor and patient guidelines for Guidant devices

June 17, 2005 - Guidant Announces Recall of Nearly 50,000 Defibrillators
Guidant announces recall of cardiac defibrillator devices. Advisory states that a magnetic switch in these devices may get stuck in the closed position, which in some cases inhibits their ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion. The recall includes the Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155).

June 24, 2005 - Guidant Expands Defibrillator Recall
Guidant announces an additional 46,000 defibrillator devices are potentially defective. Advisory includes all serial numbers of its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF defibrillator devices.

July 1, 2005 - FDA Classifies Defibrillator Recall as Class I
FDA classifies the recall of certain Guidant defibrillator models as a Class I recall, the most serious level of product recall. The models given Class I status include: Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155.) The models given Class II status, meaning that any injury caused by a malfunction should be temporary or reversible, include: Ventak Prizm AVT, Vitality AVT, Renewal AVT, Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RF.

July 18, 2005 - Guidant Alerts Physicians to Potential Flaw in Pacemakers
Guidant issues safety advisory for the Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II and Contak TR pacemaker devices, alerting physicians and patients that the sealing component in the pacemakers can degrade, resulting in higher-than-normal moisture in the devices and possible malfunction.

July 22, 2005 - Guidant Updates Original Recommendations to Physicians
Guidant announces that a software fix for recalled defibrillators it had recommended on June 17, 2005, to prevent possible device failure did not appear to solve the problem and can significantly increase the risk to patients

September 22, 2005 - Guidant Recalls some Insignia and Nexus Pacemakers
Guidant issues a recall for some of its Insignia and Nexus implantable pacemakers because of failures, including nine cases requiring emergency hospitalization. Guidant said that as of September 6, 36 out of 49,500 devices experienced loss of pacing output, while 16 out of 341,000 devices suffered a telemetry failures.

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