Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU, INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065, INTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075, INTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU

FDA Recall Z-2694-2026 · Posted 2026-07-08

Recalling FirmBoston Scientific Neuromodulation Corporation
Recall StatusOpen, Classified
Product CodeGXI
Date Initiated2026-04-22
Product Quantity37,764

Reason for Recall

Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.

Firm Action

On 4/22/2026, removal notices were mailed to materials managers and health care professionals who were asked to do the following: 1) Segregate affected devices until they can be returned to firm. 2) Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. 3) Forward this notice to any healthcare professional from your organization for awareness and to any organization to which affected devices have been transferred. 4) Complete and return the enclosed Reply Verification Tracking Form via email to [email protected] Any adverse events or quality concerns associated with use of these devices should be reported to firm via email at mailto: [email protected] or

Root Cause

Packaging process control

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of NJ, WI, MI, MN, AR, UT, OH, FL, CA, TX, PA, AZ, IN, LA, NE, OK, NY, MD, WY, CO, NC, IL, GA, WA, KS, AL, MO, VA, TN, KY, MS, MA, SC, OR, WV, MT, ID, SD, CT, NV, ND, NH, DE, NM, AK, IA, DC, HI, ME, VT, RI and the countries of Great Britain, Germany, United Arab Emirates.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑