| | Class 2 Device Recall TCD Electrodes |  |
| Date Initiated by Firm | October 05, 2026 |
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| Date Posted | November 06, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0368-2027 |
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| Recall Event ID |
100005 |
| 510(K)Number | K082012 |
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| Product Classification |
Probe, radiofrequency lesion - Product Code GXI
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| Product | TCD Electrodes (Description/REF(Inner/Outer)):
TCD Electrode, Multi-Pack, 3M Cable, 10cm x 28ga (0.36mm)/(TCD-10-3M/TCD-10-3M-P);
TCD Electrode, Multi-Pack, 10cm x 28ga (0.36mm)/(TCD-10/TCD-10-P);
TCD Electrode, Multi-Pack, 3M Cable, 15cm x 28ga (0.36mm)/(TCD-15-3M/TCD-15-3M-P);
TCD Electrode, Multi-Pack, 15cm x 28ga (0.36mm)/(TCD-15/TCD-15-P);
TCD Electrode, Multi-Pack, 5cm x 28ga (0.36mm)/(TCD-5/TCD-5-P); |
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| Code Information |
Inner REF/UDI-DI/Lot(Expiration):
TCD-10-3M/00813250014396/39749333(7/6/2030), 85009822(7/12/2030);
TCD-10/00813250010978/39741131(7/5/2030), 39750861(7/6/2030), 39757187(7/7/2030), 39766608(7/8/2030), 39768774(7/8/2030), 39772208(7/9/2030), 39778427(7/9/2030), 39780344(7/9/2030), 39781367(7/10/2030), 85006486(7/12/2030), 85011925(7/13/2030);
TCD-15-3M/00813250014402/39770714(7/8/2030);
TCD-15/00813250010985/39741129(7/5/2030), 39746187(7/6/2030), 39780349(7/10/2030), 39783782(7/10/2030);
TCD-5/00813250010961/39751579(7/7/2030), 39783599(7/10/2030) |
| FEI Number |
3006630150
|
Recalling Firm/
Manufacturer |
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia
CA
91355-5004
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| For Additional Information Contact | Renee Archie
508-683-4523 |
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Manufacturer Reason
for Recall | Radiofrequency probes may have small cut marks on the Tyvek side of the sterile pouch, and if the sterile barrier is compromised and devices are used, this could cause microbial or other foreign material contamination to be introduced into patient tissue, which may lead to infection, pain, inflammation, allergic reaction, toxicity, the need for additional medical and/or surgical intervention. |
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FDA Determined
Cause 2 | Packaging change control |
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| Action | On 10/5/2026, removal notices were mailed to Materials Managers and Healthcare Professionals who were asked to do the following:
1) Stop further use or distribution and segregate affected product. Because the cut marks associated with this removal may be small and difficult to identify, do not rely on visual inspection to determine whether products are safe to use.
2) No additional follow-up is recommended for patients previously treated with affected
product.
3) Return product to Boston Scientific in accordance with the notice instructions.
4) Forward this notice to relevant personnel and any facilities to which the product was
transferred.
5) Complete and return the Reply Verification Tracking Form via email to BSCFieldActionCenter@bsci.com
Report any adverse events or quality concerns associated with use of these devices to the firm via email at BSCComplaints@bsci.com |
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| Quantity in Commerce | 13320 |
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| Distribution | US Nationwide distribution including in the states of OH, ID, KY, NJ, GA, NY, MO, SC, MN, IA, MI, MA, WI, TX, ME, IN, AR, CO, IL, VT, VA, MS, WA, OR, NV, AZ, UT, FL, WY, CA, OK, NC, TN, MD, DE, LA, HI, CT, WV, AL, NH, ND.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = GXI
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