Atricure Inc recalls Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for…

Recall date

November 21, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0895-2015

FDA classification

Class II

Brand / firm

Atricure Inc

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of: Canada, ITALY, NETHERLANDS, CZECH REPUBLIC, AUSTRIA, GERMANY, BELGIUM, Hong Kong, SPAIN, UNITED KINGDOM (GREAT BRITAIN), UNITED KINGDOM, JAPAN, FRANCE, FINLAND, LUXEMBOURG, Korea, SWITZERLAND, SWEDEN, Malaysia, ISRAEL, NORWAY, AUSAtralia,…

Why it was recalled

Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway.