Edwards Lifesciences, LLC: Medical Device Recall in 2015 - (Recall #: Z-0398-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Thin-Flex Venous Cannula, Model Number:TF292902A

Product Classification:

Class II

Date Initiated: November 4, 2015

Date Posted: December 16, 2015

Recall Number: Z-0398-2016

Event ID: 72667

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.

Status: Terminated

Product Quantity: 8,915 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated