Z-0538-2007

Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular...

Name: Z-0538-2007 Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular...
Creator: Biosense Webster, Inc.
Published: 2006-11-17
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2006-11-17 / Terminated

FDA source

Biosense Webster, Inc. began a recall of Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog... on 2006-11-17. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0538-2007
Status: Terminated
Initiated: 2006-11-17
Posted: 2007-02-28
Terminated: 2009-06-25
Recalling firm: Biosense Webster Inc
Product: Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803M
Product code: DYB Introducer, Catheter
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 26,173
Distribution: Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.
Product codes and lots: Lot numbers: 13070988, 13070989, 13070990, 13076034, 13076424, 13078567, 13080115, 13080116, 13082796, 13085573, 13085574, 13088352, 13088353, 13091447, 13093420, 13093421, 13096355, 13099291, 13109368, L0104097, L0104215, L0104266, L0105104, L0105214, L0106131, L0106132, L0106208, L0106234, L0106270, L0106285, L0204006, L0204061, L0204111, L0204167, L0204238, L0205091, L0205143, L0205192, L0206043, L0206068, L0206124, L0206125, L0206151, L0206191, L0206192, L0206218, L0206219, L0206234, L0304028, L0304057, L0304183, L0304236, L0304299, L0306043, L0306063, L0306083, L0306110, L0306158, L0306159, L0306208, L0306283, L0404094, L0404117, L0404178, L0503121, L0503213, L0504077, L0504275, L0505136, L0505137, L0505220, L0505268, L0603074, L0603133, L0603177, L0603236, L0604058, L0604088, L0604144, L0604188, L0604208, L0604209, L0604210, L0604241, L0605013, L0605214, L0702464, L0704071, L0704146, L0704226, L0704270, L0704299, L0802069, L0803131, L0804040, L0804100, L0804171, L0804296, L0805078, L0805118, L0805163, L0805226, L0902225, L0902617, L0903105, L0903142, L0903195, L0904055, L0904070, L0904133, L0904149, L0904191, L0904224, L0905030, L0905120, L1002270, L1003019, L1003256, L1004024, L1 004056, L1004186, L1005083, L1005085, L1005200, L1005274, L1103144, L1104011, L1104268, L1105121, L1203210, L1204008, L1205168, L1205169, L204167 & LO604088

Product code DYB

K001139Class IIPreface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103MBiosense Webster, Inc. / cleared 2000-05-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)