Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decomp

FDA device recall Z-2485-2025 · posted 2025-09-02 · Open, Classified

Recall details

Recalling firm

Boston Scientific Neuromodulation Corporation

Reason for recall

As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

Action taken

On 06/06/2025, the firm sent an "Urgent Medical Device Removal - Immediate Action Required" Letter to customers inform them that, as a result of a comprehensive performance review of the Superion system and have determined that it is not meeting expected performance levels during the implantation procedure which includes breakage of the instrument (e.g., driver tip and insertion tool) and the device (e.g., spindle cap). Customer are instructed to: Physicians should stop all implants of the Superion Indirect Decompression System. Further distribution or use of any remaining affected product should cease immediately. This recall notification does not apply to Superion devices that have already been implanted and they can continue to remain in use. Boston Scientific is not recommending explant of successfully implanted Superion devices. 1. Continue to report all device-related incidents or quality concerns experienced with the Superion Indirect Decompression System to Boston Scientific. 2. Please segregate all Superion Indirect Decompression System product immediately and return it to Boston Scientific in accordance with the enclosed instructions. Complete and return the RVTF to get a Return Goods Authorization (RGA) number. "Indicate the quantity of SINGLE units you will be returning for credit "If you have product that is listed in Attachment 1 (Affected Products) that is not included on your RVTF, provide the material number, lot number, and quantity you intend to return on your RVTF "Return the RVTF via: Email: BSCFieldActionCenter@bsci.com, or Fax: BSC Field Action Center 1-763-415-7708 Public Contact - Renee Archie 508-683-4523 or email Renee.Archie@bsci.com

Root cause

Device Design

Status

Open, Classified

Product code

NQO

Quantity affected

70,516

Distribution

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH,

Date initiated

2025-06-06

Date posted

2025-09-02

Location

Valencia, CA