CLASS II ONGOING Device recall · Reported 9 Nov 2022 · FDA Enforcement Report
Thermocool Smarttouch SF Bi-Directional Navigation Catheter recalled
Johnson & Johnson Surgical Vision is recalling Thermocool Smarttouch SF Bi-Directional Navigation Catheter, distributed nationwide in the US. The recall was initiated on 7 Sep 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0169-2023
- FDA event ID
- 90887
- Recalling firm
- Johnson & Johnson Surgical Vision, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Sep 2022
- FDA classified
- 2 Nov 2022
- Reported
- 9 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 7 Sep 2022 | Recall initiated by company | |
| 2 Nov 2022 | Classified by FDA | +56 days |
| 9 Nov 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was 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.
Nationwide ColoradoFloridaGeorgiaIllinoisMichiganMissouriNorth CarolinaNew JerseyOhioOregonSouth DakotaTennesseeTexasVirginiaWisconsin
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI/Lots: 10846835010183/30779056L, 30808001L, 30814782L, 30814783L, 30779172L
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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