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.
FDA Recall Z-0169-2023 · Posted 2022-11-02
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Recalling FirmJohnson & Johnson Surgical Vision, Inc.
Recall StatusOpen, Classified
Product CodeOAD
Date Initiated2022-09-07
Product Quantity91
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.
Firm Action
On 09/07/2022, recall notices were mailed and emailed to customers requesting the following:
1) Ensure that anyone in your facility who needs to be aware of this notification reads the notice carefully.
2) If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this letter to the relevant personnel.
3) Discard/Destroy the device as per your standard disposal process, ensuring it cannot be used.
4) Complete and return the business response form.
Questions can be directed to the recalling firm representative. The following email address was provided: [email protected]
Root Cause
Process control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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