On Tuesday, the pacemaker manufacturer Guidant stated that it received a warning letter from the FDA, based on a previous agency inspection of a rhythm management facility in St. Paul, Minnesota. Since this inspection, Guidant has been required to provide monthly progressive updates, and has completed 90% of its commitments. The new letter, received by guidant on Friday the 23rd of December, states that the company will continue to receive information on additional steps necessary, as a result of this inspection.
The FDA’s assertive nature and white-glove insistance on perfection should prove to any consumer that defective medical devices should not, under any circumstances, be tolerated. The manufacturer holds total responsibility for the product it sets forth into the market. Don’t let product malfunction hurt you or your loved ones beyond physical injury, consult experienced product liability attorneys.
