Z-0169-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 9, 2022
- Initiation Date
- September 7, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 91
Product Description
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.
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.
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.
Code Information
UDI-DI/Lots: 10846835010183/30779056L, 30808001L, 30814782L, 30814783L, 30779172L