Product Wiki · Recalls · U.S. FDA — Device Enforcement

Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon… — recall Z-2756-2016

U.S. FDA — Device Enforcement · United States · 2016-08-12 · Class II

As described by U.S. FDA — Device Enforcement: Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chlo

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2756-2016
Date of alert
2016-08-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Sorin Group USA, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.
Reported risk: Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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