Feds Subpoena Heart Device Companies

By: Ed Kensik

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Federal prosecutors have subpoenaed documents from several medical device companies related to implanted heart devices.
  Subpoenas, which came from the U.S. Attorney’s Office in Boston, MA, were sent to at least three medical device giants including St. Paul, MN-based St. Jude Medical, Minneapolis, MN-based Medtronic and Indianapolis, IN-based Guidant.
  In addition, the U.S. Attorney in Minneapolis, MN has asked for documents specifically pertaining to Guidant’s Ventak Prizm 2 and Contak Renewal 1 and 2 devices. Older models of the Ventak Prizm and Contak Renewal devices were the subject of recalls earlier this year.
  In response to the subpoenas, Medtronic issued a release only stating that they received it and that they “intend to fully cooperate” with the attorney’s office. The other two companies issued similar statements.
  Since June, Guidant has recalled or issued warnings about 88,000 heart defibrillators and almost 200,000 pacemakers because of reported malfunctions. Patients and shareholders have sued, and FDA is reportedly conducting a criminal investigation. Guidant is in the process of being bought by Johnson & Johnson.

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