Johnson & Johnson Surgical Vision, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0169-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 7, 2022

Date Posted: November 9, 2022

Recall Number: Z-0169-2023

Event ID: 90887

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 91

Code Information:

UDI-DI/Lots: 10846835010183/30779056L, 30808001L, 30814782L, 30814783L, 30779172L

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated