Recall Z-0169-2023 ยท OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Johnson & Johnson Surgical Vision, Inc.
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.
| Date | Nov 2, 2022 (initiated Sep 7, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On 09/07/2022, recall notices were mailed and emailed to customers requesting the following: 1) Ensure that anyone in your facility who needs to be aware of this notification reads the notice carefully. 2) If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this letter to the relevant personnel. 3) Discard/Destroy the device as per your standard disposal process, ensuring it cannot be used. 4) Complete and return the business response form. Questions can be directed to the recalling firm representative. The following email addr |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.