Z-1101-06

Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the...

Name: Z-1101-06 Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the...
Creator: Ethicon, Inc.
Published: 2006-04-27
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2006-04-27 / Terminated

FDA source

Ethicon, Inc. began a recall of Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242... on 2006-04-27. The reason FDA records is "During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1101-06
Status: Terminated
Initiated: 2006-04-27
Posted: 2006-06-09
Terminated: 2008-12-03
Recalling firm: Ethicon, Inc
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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.
FDA root cause: Other
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.
Quantity in commerce: 368
Distribution: 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.
Product codes and lots: Product Code DFK24 Lot Numbers: MS0206031; MS0206032; MS0505014; MS0505020; MS0605009; MS0605038; MS0605039; MS0705034; MS0705035; MS0705044; MS0905040; MS0905066; MS1105041; MS1105061; MS1205043.

Product code DWF

K990772Class IIDirectflow Arterial CannulaHeartport, Inc. / cleared 1999-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)