Z-1095-06

Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm., Edwards Lifesciences

Name: Z-1095-06 Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm., Edwards Lifesciences
Creator: Edwards Lifesciences Research Medical, Inc.
Published: 2006-04-18
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2006-04-18 / Terminated

FDA source

Edwards Lifesciences Research Medical, Inc. began a recall of Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm., Edwards Lifesciences on 2006-04-18. The reason FDA records is "Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1095-06
Status: Terminated
Initiated: 2006-04-18
Posted: 2006-06-09
Terminated: 2008-06-11
Recalling firm: Edwards Lifesciences LLC
Product: Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm., Edwards Lifesciences
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use.
FDA root cause: Other
Action: Consignees were notified by letter and visit beginning 04/18/2006.
Quantity in commerce: 30 units (Domestic), 30 units (Foreign)
Distribution: CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
Product codes and lots: REF: MT022TA. Lot numbers 58208130, 58216517.

Product code DWF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)