Guidant advises physicians about Renewal cardiac defibrillators, possible FDA recall

By Lisa Kerner

Erie, Pa., March 13 - Guidant Corp. said it is voluntarily advising physicians about important product information regarding Contac Renewal 3 RF and Renewal 4 RF cardiac defibrillators.

The company has also informed the Food and Drug Administration of this action and, according to a news release, the FDA may classify this communication action as a recall.

Guidant has received 39 reports of pre-implant devices that exhibited lower-than-expected battery voltage. None of these devices were implanted.

The company confirmed that the decline in battery voltage is related to an unexpected sustained, low-level current occurring during storage/shipment mode prior to implant.

Guidant said it has not received any reports of abnormal battery voltage in the approximately 4,000 implanted Renewal 3 RF and Renewal 4 RF devices.

Physicians, or their Guidant sales representatives, are advised to screen the shelf inventory using the process outlined by the company.

Additional information is available on Guidant's web site at www.guidant.com/physician_communications/RenewalRF.pdf.

Guidant, based in Indianapolis, designs and develops cardiovascular medical products.

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