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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0169-2023
Event ID90887
Event DescriptionTHERMOCOOL 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 TypeDevices
DistributionWorldwide - 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.
Quantity91
Recall ReasonManufacturing 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 Classification20221109
Device Code InfoUDI-DI/Lots: 10846835010183/30779056L, 30808001L, 30814782L, 30814783L, 30779172L
Center Classification Date20221102
Recall Initiation Date20220907
Recalling FirmJohnson & Johnson Surgical Vision, Inc.
Initial Notification Letter
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