Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS

FDA device recall Z-2694-2026 · posted 2026-07-08 · Open, Classified

Recall details

Recalling firm

Boston Scientific Neuromodulation Corporation

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.

Action taken

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 BSCFieldActionCenter@bsci.com Any adverse events or quality concerns associated with use of these devices should be reported to firm via email at mailto: BSCcomplaints@bsci.com or

Root cause

Packaging process control

Status

Open, Classified

Product code

GXI

Quantity affected

37,764

Distribution

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

Date initiated

2026-04-22

Date posted

2026-07-08

Location

Valencia, CA

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