# FDA recall Z-0056-2018

> **Biosense Webster, Inc.** · Class II · device recall initiated 2017-09-06.

## Product

THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)

## 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.

## 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

## Key facts

- **Recall number:** Z-0056-2018
- **Recalling firm:** Biosense Webster, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-06
- **Report date:** 2017-11-08
- **Termination date:** 2019-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irwindale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0056-2018

## Citation

> AI Analytics. FDA recall Z-0056-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0056-2018. Source: US FDA. Licensed CC0.

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