THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter — Class II medical device recall Z-0057-2018
Terminated recall by Biosense Webster, Inc., reported 2017-11-08. Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert
| Recall number | Z-0057-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2017-09-06 |
| Classified | 2017-10-27 |
| Reported by FDA | 2017-11-08 |
| Terminated | 2019-11-19 |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CN, CO, CZ, DE, DK, FI, FR, GB, HR, HU, IE, IT, JP, KR, NL, NZ, PL, PT, SE, ZA |
| Quantity | 19 units |
Product
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0057-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.