Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0054-2018 — THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S

U.S. FDA — Device Enforcement · United States · 2017-09-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0054-2018
Date of alert
2017-09-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biosense Webster, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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