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FDA Warns Guidant About Its Heart Devices

December 28, 2005

• Medtronic Withdaws Defibrillator Wires • Guidant Settles Defibrillator Charges For $16.7 Million • Court Orders Guidant To Release Documents • FDA Warns Guidant About Its Heart Devices • Spitzer Sues Guidant for Hiding Defibrillator Defect • FDA Report Addresses Heart Device Malfunctions • Potentially Harmful Medical Devices Should Be Recalled, Public Citizen Tells FDA • FDA Knew Of Pacemaker Problems Before Recall • Guidant To Resume Defibrillator Sales • Guidant Recalls Pacemakers • Guidant Pacemakers May Be Recalled • FDA Upgrades Guidant Recalls • Guidant Finds More Defibrillator Problems • FDA Recalls Guidant Implantable Defibrillators • Company Withheld News of Flaw in Defibrillator • Medicare To Cover More Defibrillators

The Food and Drug Administration has warned Guidant that, in the agency's opinion, it has not resolved the manufacturing problems detected in an earlier inspection. In a letter to the company, the FDA said that would likely result in restrictions on its ability to bring new heart devices to the market.

The company acknowledged the letter, saying it relates to the FDA's inspection of Guidant's Cardiac Rhythm Management facility in St. Paul, Minn. The FDA inspection was completed on September 1, 2005.

Guidant said it has taken a "broad, thorough and systemic review of its quality system and has made substantial steps" toward addressing the problems noted during the inspection.

Guidant said it has provided the FDA with monthly updates on its progress and has thus far completed 90 percent of the commitments that it made in its initial response. The company added it is also expecting an on-time completion of the remaining commitments.

The FDA letter, received December 23, 2005, references many of the inspectors' observations, noting actions taken by Guidant to address the observations and noting that Guidant will receive future communication regarding observations requiring additional action.

The FDA letter also indicates that the FDA will not grant requests for exportation certificates to foreign governments or approve pre-market approval applications for class III devices that relate to observations requiring additional action, until such action has been completed.

The company said it will promptly respond to the warning letter and believes that it can fully address the concerns of the FDA without a material impact to its business.

Guidant was plagued throughout 2005 by problems with its cardiac defibrillator.

In June Guidant recalled 88,000 defibrillators and 28,000 pacemakers because of potential problems. The company blamed the recalls on "small, residual imperfections." The FDA ordered the recalls because of a faulty switch. The electronic devices are supposed to deliver a shock to the heart when they detect an arrythmia.

In August the FDA gave permission to Guidant to resume sales of its cardiac defibrillator after the company assured the agency the switch problem had been resolved.

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