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.
Johnson & Johnson Surgical Vision is recalling a specific cardiac catheter model because manufacturing errors might have contaminated it with cellulose fibers. This could lead to irrigation failure, increased catheter tip temperature, or toxic effects during cardiac procedures.
The catheter's irrigation path could contain cellulose fibers from a manufacturing error. This might cause the irrigation to fail during use, raise the catheter tip temperature, or allow particles to enter the bloodstream causing potential toxicity.
Healthcare professionals using the recalled catheter for cardiac procedures are most at risk. Patients undergoing cardiac ablation with this specific model may be affected.
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.
Look for the specific serial numbers listed in the recall notice on the catheter packaging or label.
The recall indicates a potential contamination risk, so it is not recommended for use until the remedy is applied. However, the remedy is not specified in the recall notice.
The recall notice does not specify a remedy, so contact Johnson & Johnson Surgical Vision directly for guidance.
Check for the model name 'Thermocoool Smarttouch SF Bi-Directional Navigation Catheter' and the serial numbers listed in the recall notice.
We’ve drafted a message you can send Johnson & Johnson Surgical Vision to request your refund or repair — edit it as you like.
Subject: Recall Z-0169-2023 — Johnson & Johnson Surgical Vision Johnson & Johnson Surgical Vision Hello, I own a Johnson & Johnson Surgical Vision that is covered by recall Z-0169-2023 from Johnson & Johnson Surgical Vision. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
