Biosense Webster, Inc. EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation.
Brand
Biosense Webster, Inc.
Lot Codes / Batch Numbers
Lot Number: 13140790A
Products Sold
Lot Number: 13140790A
Biosense Webster, Inc. is recalling EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter due to The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expira. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009.
Recommended Action
Per FDA guidance
The firm, Biosense Webster, sent a "Medical Device-Voluntary Field Removal" letter dated December 17, 2007 to its customer. The letter identified the product, problem and an action to be taken. The customer was instructed to complete and return the Product Voluntary Field Removal Certification Form via fax to Quality Compliance at (909) 839-7207or mail using the enclosed self-addressed stamped envelope. If you have additional questions, please follow up with your local Biosense Webster representative.or contact Customer Service at (909) 839-8500.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026