Boston Scientific Neuromodulation Corporation: Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual

Recall number

Z-1972-2023

Recalling firm

Boston Scientific Neuromodulation Corporation

Product

Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual

Status

Open, Classified

Initiated

2023-05-12

Posted

2023-06-15

Terminated

not on file

Reason

Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.

Root cause

Labeling design

Action

On 05/12/23, correction notices were mailed to physicians/surgeons, hospitals, healthcare professionals who were advised the following: IFU advises against forced deployment, as it could result in device breakage. Correction notice advises to review of the IFUs/Surgical Technique Manual. Avoid application of excessive force, use only two or three fingers when performing final tightening during device deployment). Inspect Driver instrument prior to/following use; if Driver tip break is noted: Retrieve metal fragment(s), consider performing imaging. Missing/bent teeth prevents Driver engagement with implant and requires exchange for a new/replacement Driver instrument to complete successful deployment. If metal fragment(s) are not successfully removed: MRI scans are NOT advised, Append the patient s medical record with a copy of this letter to maintain awareness of metal fragment(s) remaining in situ for the remaining service life of the device. Consider alternative imaging for patients with metal fragment(s) remaining in situ, e.g., X-ray/ultrasound/CT scan. Distributors asked to notify all customers that have been shipped/sold affected product. Complete/return acknowledgement form to BSCFieldActionCenter@bsci.com or Fax to: Field Action Center (1-866-213-1806). Driver tip breakage can be identified via an audible click, a loss of tactile resistance during the implant procedure, and/or visual detection following removal of the Driver instrument from the inserter tool and subsequent inspection. Adverse events or quality concerns should be reported to BSN.ComplaintCallCenter@bsci.com. If you have any question, contact Senior Management Quality: at 651-581-0761 or email: rebecca.kinkead@bsci.com Firm is updating IFU to advise against MRI scanning for patients with unretrieved metal fragments. A separate letter was sent to health care professions providing them with a patient letter. Patient letter states firm recommends patients discuss this letter with t

Quantity

21,533

Distribution

US Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK, MO, MI, OH, WV, NC, UT, NH, CA, NJ, TN, NV, AZ, NE, IA, CT, ME, LA, KY, MS, MD, DC, GA, CO, KS, ID, MN, AR, HI, NM, WA, SD, OR, DE, WY, AK, and ND

Lot, serial or model codes

Driver UDI-DI: 00884662000574, UPN: 102-9800, All Lots. Superion Indirect Decompression System IFU (92479815-02), Superion IDS Kit IFU (92479820-02), Surgical Technique Manual (92479821-02)

510(k) numbers

not on file

PMA numbers

P140004

Product code

NQO

Firm FEI

3006630150

Firm city

Valencia

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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