Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Baxter Flo-Thru Intraluminal Shunt Recalled by Baxter Healthcare Corporation Due to Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corporation directly.
Affected Products
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Product Code FT12200, 2.00 GLOBAL; f) Product Code FT12225, 2.25 GLOBAL; g) Product Code FT12250, 2.50 GLOBAL; h) Product Code FT12275, 2.75 GLOBAL; i) Product Code FT12300, 3.00 GLOBAL
Why Was This Recalled?
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Baxter Healthcare Corporation
Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report