Ethicon, Inc. US 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Ethicon, Inc. US
Lot Codes / Batch Numbers
Product Code DFK24 Lot Numbers: MS0206031, MS0206032, MS0505014, MS0505020, MS0605009, MS0605038, MS0605039, MS0705034, MS0705035, MS0705044, MS0905040, MS0905066, MS1105041, MS1105061, MS1205043.
Products Sold
Product Code DFK24 Lot Numbers: MS0206031; MS0206032; MS0505014; MS0505020; MS0605009; MS0605038; MS0605039; MS0705034; MS0705035; MS0705044; MS0905040; MS0905066; MS1105041; MS1105061; MS1205043.
Ethicon, Inc. US is recalling Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also due to During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026