Recall Z-0539-2007 ยท DYB Introducer, Catheter
Biosense Webster, Inc.
Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301805M
| Date | Feb 28, 2007 (initiated Nov 17, 2006) |
| Status | Terminated |
| Reason | 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. |
| 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 Manageme |
| Quantity | 996 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001139 | PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M Biosense Webster, Inc., May 10, 2000 |