THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation recall: Contamination
THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping…
Why was THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI/Lots: 10846835010183/30779056L, 30808001L, 30814782L, 30814783L, 30779172L
- Product
- THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping…
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Quantity
- 91
- 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.
- Recall date
- November 9, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)