Contact Us

Guidant Defibrillators
*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 


Cell Phone 

Street Address 

Zip Code 



Which Guidant cardiac defibrillator was implanted?

If other, what is the name of the defibrillator that was implanted?

Date the device was implanted:

Is the device still implanted?

What medical condition prompted the use of the device?

Please describe any problems or injuries caused by the product:

For verification purposes, please answer the below question:

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.

Guidant Gets FDA Warning Letter on Facility

Dec 27, 2005 | AP Guidant Corp., one of the nation's top makers of pacemakers and heart defibrillators, said Tuesday that it received a warning letter from federal regulators regarding its operations in St. Paul, Minn.

Guidant said the warning, which comes from the Food and Drug Administration, is for the company's manufacturing, research and sales center in St. Paul. The FDA finished an inspection of the center, known as the company's Cardiac Rhythm Management facility, in September.

Guidant received the FDA's warning letter last Friday. The letter indicates that the FDA won't grant any of the company's requests for exportation certificates to foreign governments, or approve the company's applications for certain medical devices until Guidant takes steps to resolve the agency's concerns.

Guidant said it has thoroughly reviewed its St. Paul system and has made substantial steps toward addressing all the FDA's observations that prompted the warning letter. The company also said it believes it can fully address the FDA's concerns without seriously affecting its business.

The company disclosed in September that the FDA had raised some concerns about its St. Paul operations. The company said at the time that it planned to improve its product labeling and provide more frequent and detailed product performance reports, but Guidant hadn't yet received a response from the FDA.

Related articles Other articles
Parker Waichman Accolades And Reviews Best Lawyers Find Us On Avvo