THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter — Class II medical device recall Z-0169-2023

Ongoing recall by Johnson & Johnson Surgical Vision, Inc., reported 2022-11-09, distributed nationwide. Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path

Recall number	`Z-0169-2023`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Johnson & Johnson Surgical Vision, Inc., Irvine, CA, United States
Recall initiated	2022-09-07
Classified	2022-11-02
Reported by FDA	2022-11-09
Distributed	Nationwide (US)
Countries outside the US	DE, HR, HU
Quantity	91
UPC / GTIN / UDI-DI	`10846835010183`
Lot numbers	`10846835010183/30779056L`, `30779172L`, `30808001L`, `30814782L`, `30814783L`
Model numbers	`D-1348-05-S`

Product

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.

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.

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-0169-2023. 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.