Guidant reports 18 more device failures
New malfunctions with implantable defibrillators detailed in letter to doctorsDec 30, 2005 | www.indystar.com
The Food and Drug Administration, in a letter to physicians, said it has received 18 more reports of Guidant heart implants failing.
Guidant now has reported 67 failures since problems surfaced with its implantable defibrillators in June. Seven deaths have been linked to the implant failures.
Indianapolis-based Guidant reported 14 more clinical failures with its Contak Renewal defibrillators, bringing total failures for that device to 35. Guidant also reported four more failures of its Ventak Prizm defibrillators, bringing its total to 32.
Guidant posted its own letter to physicians, detailing the additional failures, on Dec. 21. The letter was dated Dec. 20.
Guidant spokeswoman Annette Ruzicka, when asked to comment, referred to those letters on Guidant's Web site.
Since June, Guidant has recalled more than 100,000 of its defibrillators.
The company is undergoing scrutiny from the FDA to see if it followed reporting requirements. Dozens of lawsuits have been filed against Guidant, alleging it concealed vital information from patients.
The suits claim Guidant should not have waited to disclose the weakness in some of its devices, which it discovered in 2002.
Shares edged down 29 cents Thursday to close at $64.85.
Guidant is being wooed as a merger partner by two rival companies, Johnson & Johnson and Boston Scientific.