FDA: More Guidant ICD defects reported

WASHINGTON, Dec. 29 (UPI) -- Guidant has reported 18 more failures associated with its cardiac defibrillators, regulators said this week.

In a statement issued Wednesday, officials from the Food and Drug Administration said Guidant has informed the agency of 14 additional clinical failures for the Contak Renewal and Contak Renewal 2 implantable cardiac defibrillators since the FDA's most recent update on the devices Oct. 13.

The FDA said that, since Dec. 21, there have been a total of 35 clinical failures of the Contak Renewal devices worldwide, of which the agency said it has confirmed 20, including give patient deaths.

"You should take these failures into account as you continue to follow the patients who have either RENEWAL model subject to the recall," the FDA told healthcare providers.

The agency said Guidant also reported 4 additional clinical failures for the Ventak Prizm 2DR ICD since the agency's October 13 notice, including one patient death. As of Dec. 21 there have been a total of 32 clinical failures of this brand of Guidant ICD worldwide, with 30 confirmed, including two patient deaths, the FDA said.

"There are likely to be additional clinical occurrences in the future, and we will provide updates as this information becomes available," the agency said.

The two Guidant ICD product series were the subject of a Class I recall last July after the discovery a possible internal short that could prevent the devices from delivering a defibrillator shock to restart the heart when needed.