Johnson & Johnson Surgical Vision, Inc. Recall 90887
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.
Johnson & Johnson Surgical Vision, Inc. Recall 90887 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0169-2023 |
| Event ID | 90887 |
| Event 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. |
| Product Type | Devices |
| 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. |
| Quantity | 91 |
| Recall Reason | 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. |
| Device Classification | 20221109 |
| Device Code Info | UDI-DI/Lots: 10846835010183/30779056L, 30808001L, 30814782L, 30814783L, 30779172L |
| Center Classification Date | 20221102 |
| Recall Initiation Date | 20220907 |
| Recalling Firm | Johnson & Johnson Surgical Vision, Inc. |
| Initial Notification | Letter |
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