Recall Z-0058-2018 ยท LPB Cardiac Ablation Percutaneous Catheter
Biosense Webster, Inc.
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
| Date | Sep 6, 2017 |
| Status | Terminated |
| Reason | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy. |
| Root cause | Under Investigation by firm |
| Action | All US and OUS customers, who have purchased the lots identified as part of this recall will be notified via customer letters in order to return the product to BWI facility where it will be segregated for further disposition. This product recall applies to hospitals (or direct customers) and distributors who have purchased and/or received the THERMOCOOL Catheters identified as part of this recall . One notification package which includes the Customer Notification Letter, Business Reply Form (B RF) and pre-paid return label will be distributed to the customers subject to this recall via a 3rd |
| Quantity | 329 units |
| Distribution | US, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.