Lower riskMedical device recall · FDA · Published September 7, 2022
Johnson & Johnson Surgical Vision Recalls Thermocoool Smarttouch SF Catheter Due
Johnson & Johnson Surgical Vision recalls Thermocoool Smarttouch SF Bi-Directional Navigation Catheters (REF: D-1348-05-S) due to potential cellulose fiber contamination that could cause irrigation failure or temperature issues during cardiac procedures.
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.
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Contact the company
📍Recalling firmJohnson & Johnson Surgical Vision, Inc.31 Technology Dr Ste 200 · Irvine, CA 92618-2302
“Johnson & Johnson Surgical Vision Recalls Thermocoool Smarttouch SF Catheter Due.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60083-johnson-johnson-surgical-vision-recalls-thermocoool-smarttouch-sf-catheter-due. Based on FDA recall #Z-0169-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0169-2023%22&limit=1).
The FDA announced on 2022-09-07 that Johnson & Johnson Surgical Vision, Inc. is recalling the THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter due to potential contamination with cellulose fibers. The agency stated the manufacturing error could cause catheter tip temperature increases or thrombogenic effects.
How to tell if you have it
Brand: Johnson & Johnson Surgical Vision
Product: THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter
According to the FDA, a manufacturing error resulted in potential contamination of the catheter irrigation path with cellulose fibers. This defect can cause failure of initial flushing inspections, insufficient irrigation leading to temperature increases, or thrombogenic/toxic effects from flushed particles.
Context
GovInfoNow's records show Johnson & Johnson Surgical Vision, Inc. has 14 other recalls on record since 2018-05-09. Other recent recalls of similar products include HEALON Products for Corneal Injury Risk (2026-07-31), Irrigation Sleeles (2024-03-14), and TECNIS Toric II IOLs with Angle Issue (2023-12-12). Other recent recalls of similar products include Medline ViewFlex Xtra ICE Catheters Recall (2025-12-22), Medline convenience kits with Bard Silastic catheters recalled (2026-06-08), and Stryker Daig Livewire Steerable Catheter Recall (2026-04-10).
How to tell if you have this one
Check for the model name 'Thermocoool Smarttouch SF Bi-Directional Navigation Catheter' and the serial numbers 10846835010183, 30779056L, 30808001L, 30814782L, 30814783L, or 30779172L on the packaging or label.
Brand
Johnson & Johnson Surgical Vision
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Serial Numbers
Look for the specific serial numbers listed in the recall notice on the catheter packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 15 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Colorado, Florida, Georgia, Illinois, Michigan, Missouri, New Jersey, North Carolina, Ohio, Oregon, South Dakota, Tennessee, Texas, Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0169-2023 (September 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0169-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.