Z-2401-2008

Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC...

Name: Z-2401-2008 Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC...
Creator: Edwards Lifesciences Research Medical, Inc.
Published: 2008-07-14
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2008-07-14 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences Research Medical, Inc. began a recall of Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614 Intended for cannula drainage of the... on 2008-07-14. The reason FDA records is "Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2401-2008
Status: Terminated
Initiated: 2008-07-14
Posted: 2008-09-26
Terminated: 2008-12-23
Recalling firm: Edwards Lifesciences LLC
Product: Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614 Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All domestic consignees were notified by a Product Recall letter on 07/15/2008 via FedEx. They were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards. Customers are to contact Customer Service Organization to obtain a Returned Goods Authorization number and replacement product. Once inventory has been verified, the attached form needs to be completed and faxed to Edwards so that customer awareness can be confirmed. International accounts were notified on 07/14/2008.
Quantity in commerce: 707 units
Distribution: Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.
Product codes and lots: Lot Number 58449974

Product code DWF

K831769Class IIVarious Cardiovascular Surgical DeviceResearch Industries Corp. / cleared 1983-08-12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)