Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SMARTABLATE RF System Generator Recalled by Biosense Webster, Inc. Due to Generator may inadvertently deliver RF energy if the...
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 Biosense Webster, Inc. directly.
Affected Products
SMARTABLATE RF System Generator
Quantity: 185 units total
Why Was This Recalled?
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Where Was This Sold?
This product was distributed to 15 states: CA, CO, GA, IL, IN, MI, NM, NY, OH, PA, TN, TX, UT, WA, WI
About Biosense Webster, Inc.
Biosense Webster, Inc. has 31 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