In the warning letter, which was made public Tuesday by the FDA, regulators said that they found some of St. Jude's responses to be inadequate. For example, the FDA said St. Jude did not provide evidence that it had implemented certain corrective actions. The FDA also said that St. Jude had "misbranded" its Durata lead, in that it failed to report to the FDA within 30 days after it received or became aware of information "that reasonably suggests that a device that your firm markets malfunctioned and that this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur."