Z-0398-2016Class II

Thin-Flex Venous Cannula, Model Number:TF292902A

Name: Z-0398-2016 Thin-Flex Venous Cannula, Model Number:TF292902A
Creator: Edwards Lifesciences, LLC
Published: 2015-11-04
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2015-11-04 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Thin-Flex Venous Cannula, Model Number:TF292902A on 2015-11-04. FDA classified it as Class II and gives the reason as "Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct...". 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-0398-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-04
Posted: 2015-12-09
Terminated: 2017-02-10
Recalling firm: Edwards Lifesciences LLC
Product: Thin-Flex Venous Cannula, Model Number:TF292902A
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Edwards Lifesciences sent an Urgent Medical Device Safety Notice dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer Instructions 1. Review this field safety notice to understand the potential hazard. 2. Meet and review with appropriate clinical staff at your hospital. 3. Complete and return the acknowledgement form attached to this letter via fax to (800) 422-9329 within 5 business days of receiving this notice. 4. Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred. 5. Product return is not required. Actual product is acceptable for use and is not being recalled as part of this field action. Your assistance is appreciated and necessary to ensure that this notice is reviewed and understood. We appreciate your attention, and apologize for the inconvenience caused by this matter. If you have questions that have not been answered by this letter, please call Edwards Customer Service Monday through Friday at (800) 424-3278 from 8:00AM - 4:00PM Pacific Time.
Quantity in commerce: 8,915 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates , Belgium, Czech Republic, Spain, France, United Kingdom, Italy, Kuwait, Netherlands, Romania, Saudi Arabia, Sweden, Singapore, Thailand and South Africa.
Product codes and lots: Lot No: 59384061 59677936 59985533 59430941 59723695 59999044 59456603 59746454 60010418 59498228 59779239 60106398 59545464 59846864 60113045 59580433 59883622 60121142 59608030 59931290 60172116 59649580 59963196 60181079

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0398-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0398-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-09

Product code DWF

K120072Class IIVenous Drainage Cannula with Duraflo CoatingEdwards Lifesciences, LLC / cleared 2012-05-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)