Edwards Thin-Flex Venous Cannula Recalled for Incorrect Connector Size Labeling
Edwards Lifesciences is recalling Thin-Flex Venous Cannulas because the product guide incorrectly lists the connector size as 3/8 inch instead of the actual 1/2 inch.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Moderate because it involves a minor labeling error regarding the connector size, with no reported injuries or illnesses in the source text.
Plain-English summary
Edwards Lifesciences, LLC has initiated a field action for the Thin-Flex Venous Cannula, Model Number TF292902A. The recall involves 8,915 units distributed worldwide, including the United States and various international markets.
The action was taken because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size for the device is 1/2 inch. This discrepancy is a labeling error in the product documentation.
The source text does not specify specific instructions for consumers or healthcare providers regarding the immediate handling of the device, nor does it report any illnesses or injuries associated with this labeling error.
The recalled product
- Product
- Thin-Flex Venous Cannula, Model Number:TF292902A
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Venous Cannula
- Hazard
- Affected units
- 8,915
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Edwards Lifesciences, LLC
See all →- ModerateEdwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
FDA (Devices) · 2026-05-20
- SevereFEM-FLEX II FEMII016A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI16 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II femoral arterial cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI18 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSPS Sterilization Recalls Edwards Venous Drainage Cannulas Due to Labeling Error
FDA (Devices) · 2018-09-19
- HighEdwards Lifesciences Recalls Fem-Flex II Pediatric Femoral Arterial Cannulas
FDA (Devices) · 2015-04-08
- SevereEdwards Lifesciences Recalls QuickDraw Venous Cannulas Due to Connector Separation Risk
FDA (Devices) · 2020-01-22
- ModerateSPS Sterilization Recalls Edwards Femoral Venous Cannula Due to Shelf Life Labeling Error
FDA (Devices) · 2018-09-19
- HighEdwards Recalls EndoReturn Arterial Cannula Due to Component Error
FDA (Devices) · 2013-08-21
- HighEdwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation
FDA (Devices) · 2014-04-23