FDA Demands St. Jude Take Action on Medical Device Security stat : Threat Post

The disclosure was compounded by a short position Muddy Waters held on St. Jude medical stock that allowed it and MedSec to profit should St. Jude stock drop in value. "The patch that St. Jude Medical released does not address the implants," Bone said. While Abbott and St. Jude Medical have patched some Merlin@home issues, MedSec challenged the fix, calling it incomplete. Vulnerabilities in the Merlin device and in others sold by St. Jude Medical, were at the center of a report published last August by hedge fund Muddy Waters and medical device security research company MedSec Holdings. Abbott acquired St. Jude Medical in January 2017; the FDA inspection of the Sylmar facility, formerly run by St. Jude Medical, began on February 7; and we responded to the 483 observations on March 13, describing the corrective actions we are implementing.




However, in your firm's response, you failed to provide evidence of implementation for your firm's corrections, corrective actions and systemic corrective actions. However, in your firm's response, you failed to provide evidence of implementation for your firm's corrections, corrective actions, and systemic corrective actions. However, in your firm's response, you failed to consider systemic corrective actions and the necessary information to include evidence of implementation for your firm's corrections, corrective actions, and systemic corrective actions. Your firm provided a summary of, and implementation dates for, several corrections, corrective actions, and systemic corrective actions. In your firm's response, you failed to provide a description and evidence of implementation for corrections and corrective actions, to include consideration of systemic corrective actions.


St. Jude Medical, which is now part of Abbott Laboratories, failed to appropriately correct issues found in some of its cardiovascular devices, according to the U.S. Food and addiction Administration. The FDA also said that St. Jude didn't implement appropriate corrective actions to ensure patients didn't receive defibrillators with unsafe vulnerabilities. Still, St. Jude continued to sell the older models that were recalled. Abbott acquired St. Jude in January for $25 billion. The company said it will closely review the FDA's warning letter and is "committed to fully addressing the FDA's concerns."


collected by :Lucy William

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