InjuryBoard Minneapolis Archives

• Guidant to Blame for Response to Device Failures

  Michael Johnson | March 21, 2006 2:47 PM | 0 Comments
  Category: Miscellaneous

  Guidant's own expert panel, that was assembled last summer to assess the handling of heart device flaws, stated that the company failed to fully realize the affect on patient safety when publicizing product failures.When a panel of doctors and experts investigated the method of handling the disclosures of flaws in heart devices to doctors, they discovered that Guidant used a statistical...

• Guidant failed to inform FDA changes in device

  Michael Johnson | March 07, 2006 11:33 AM | 0 Comments
  Category: Defective & Dangerous Products

  Fred McCoy, head of Guidant's cardiac rhythm management division, stated during a January 2006 deposition that Guidant altered the design of one of the company's defibrillators in 2002 and later misinformed federal regulators stating that the change had no effect on the product's performanceMcCoy went on to state,"This particular failure mechanism does not have the capacity to kill a patient. ...