FDA Device recall Z-0058-2018
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
- FDA Device
- Class II
- terminated
- Published 2017-11-08
On 2017-11-08 the FDA classified a Class II recall of THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S by Biosense Webster, citing 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 cathe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0058-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-06 |
| Published | 2017-11-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biosense Webster |
| Distribution | n/a |
Product
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
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.
Identifiers
| code_info | 17637495L 17638389L 17639706L 17639707L 17639708L 17640039L 17640494L 17640952L 17640040L 17640742L 17640…17637495L 17638389L 17639706L 17639707L 17639708L 17640039L 17640494L 17640952L 17640040L 17640742L 17640953L 17640041L 17640743L 17640954L 17640490L 17640744L 17643130L 17638118L 17638387L 17638388L |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0058-2018%22
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