Recall Z-0169-2023— Johnson & Johnson Surgical Vision, Inc.
Class II · Ongoing
Class II FDA medical device recall by Johnson & Johnson Surgical Vision, Inc., initiated 2022-09-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-07
- Firm location
- Irvine, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.