Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244.
FDA Recall Z-1101-06 · Posted 2006-06-09
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Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2006-04-27
Date Terminated2008-12-03
Product Quantity368
Reason for Recall
During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.
Firm Action
The recall was initiated on 4/27/2006. The hospitals were notified via letters to the Director of Material Management, Director of the OR as well as the Director of the Cardiovascular Suite in the US. The letters were sent via certified mail delivery. For international, notification was made to the J&J affiliates (Gargrave and Italy) by the European Authorized Representative. Each country will follow local procedures for notitying customers.
Root Cause
Other
Distribution Pattern
There are 25 direct customers. There are no distributors, wholesalers and retailers. The firm ships direct to the medical facility. There are 11 International customers located in United Kingdom and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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