Johnson & Johnson Surgical Vision, Inc. recalls THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrop…

Recall date

September 7, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0169-2023

FDA classification

Class II

Brand / firm

Johnson & Johnson Surgical Vision, Inc.

Sold / distributed

Worldwide - US Nationwide distribution in the states of NC, TN, VA, OH, MO, MI, GA, OR, MO, SD, CO, OH, FL, NJ, TX, IL, WI and the countries of CROATIA, GERMANY, HUNGARY.

Why it was recalled

Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.