Biosense Webster, Inc. Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS
Brand
Biosense Webster, Inc.
Lot Codes / Batch Numbers
Lot numbers: 13070991, 13073870, 13073873, 13080117, 13082797, 13090941, 13099292, 13103566, 13109369, L0103032, L0103066, L0103069, L0103295, L0105007, L0106017, L0106161, L0106271, L0203066, L0206045, L0206152, L0206235, L0206249, L0304237, L0306029, L0306084, L0306161, L0306209, L0404116, L0502384, L0502568, L0504042, L0602226, L0604089, L0704070, L0804173, L0902370, L0902618, L0904056, L0904071, L0904089, L0904134, L0904150, L1002219, L1004025, L1004057, L1004259, L1102088, L1102219, L1205135 & L1205189
Products Sold
Lot numbers: 13070991, 13073870, 13073873, 13080117, 13082797 , 13090941, 13099292, 13103566, 13109369, L0103032, L0103066, L0103069, L0103295, L0105007, L0106017, L0106161, L0106271, L0203066, L0206045, L0206152, L0206235, L0206249, L0304237, L0306029, L0306084, L0306161, L0306209, L0404116, L0502384, L0502568, L0504042, L0602226, L0604089, L0704070, L0804173, L0902370, L0902618, L0904056, L0904071, L0904089, L0904134, L0904150, L1002219, L1004025, L1004057, L1004259, L1102088, L1102219, L1205135 & L1205189
Biosense Webster, Inc. is recalling Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular e due to Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath duri. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
Recommended Action
Per FDA guidance
Initially a Medical Device Correction Advisory letter was mailed on November 20, 2006 to all domestic and international consignees recommending to customers that the Preface Sheath was not to be used with the NaviStar ThermoCool Catheter or any 8 French or larger catheter. On December 9, 2006, a Recall Customer letter and Certification form were sent out to all customers and Johnson & Johnson affiliates who had purchased the product in the past three years. For customers in the US, two letters and forms were sent out -one addressed to the EP/Cardiology Lab and the second to the Risk Management Office. For the US, customers will return product directly to Biosense Webster afler receiving a return authorization number. Returned product will be segregated and labeled as quarantined product. Returned product will be used as necessary for the root cause investigation. Any product not used at the conclusion of the investigation will be destroyed. For international customers, product will be returned to the Biosense Webster warehouse in Roden, Netherlands or to the Biosense Webster US warehouse (depending on order placement) if export issues don''t present a problem. If product cannot be easily returned to Biosense Webster, the customers will be instructed to destroy the product and provide notification that the destruction was performed.
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