GDT Guidant Corp

Guidant Corporation (NYSE:GDT) said today it is voluntarily advising physicians about important product information regarding CONTAK RENEWAL 3 RF and RENEWAL 4 RF devices. Guidant has apprised the United States Food and Drug Administration (FDA) of this action and the FDA may classify this communication action as a recall. Physicians should use this information to decide how best to treat their patients. Regarding pre-implant devices, Guidant has received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted. Engineering investigation has confirmed that the observed decline in battery voltage is related to an unexpected sustained, low level current that can only occur during storage/shipment mode prior to implant. Regarding implanted devices, of the approximate 4,000 RENEWAL 3 RF and RENEWAL 4 RF devices implanted to date worldwide, Guidant has received no reports of abnormal battery voltage related to this specific issue. Engineering investigation has confirmed that this internal low level current may occur transiently in normal use post implant, with negligible impact on longevity (less than two weeks over a device lifetime) and no impact on device function. Physicians are advised to screen shelf inventory using the following steps: turn off RF telemetry in the programmer (verify that RF LED indicator is off); initiate inductive interrogation and ensure that devices exhibit a BOL (beginning of life) battery voltage that is typically greater than 3.13 volts (no more than 0.1 volts below the voltage that appears on the package labeling). Guidant sales representatives are available to screen shelf inventory for physicians. Physicians should always check battery voltage when preparing for the implant procedure. Devices should exhibit a BOL battery voltage that is typically greater than 3.13 volts (no more than 0.1 volts below the voltage that appears on the package labeling). Duplicates of all implantable items and implant accessories should be available for use if needed. For implanted devices, continue normal follow-up. Guidant recognizes the impact of product performance communications on both physicians and patients. Patient safety remains Guidant's primary concern. Any updates that become available will be promptly communicated. Additional information about this potential issue is available for physicians and patients at 1-866-GUIDANT (1-866-484-3268) (24/7) and http://www.guidant.com/physician_communications/RenewalRF.pdf This release includes forward-looking statements concerning the course of developments with respect to the affected products. These statements are based on assumptions about many important factors, including continuing developments with respect to product performance, regulatory agency actions, and other factors identified on Exhibit 99 to the company's most recent 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements.