🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: May 12, 2023 Boston Scientific Neuromodulation Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    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)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Boston Scientific Neuromodulation Corporation
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1972-2023

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Class I - Dangerous

Reusable electrodes may not meet expected performance levels.

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