Boston Scientific recalls Superion Indirect Decompression System kits (8mm-16mm) due to inconsistent performance, including breakage of instruments and implants. Affected units have specific lot/batch numbers listed in the recall notice.
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.
Boston Scientific is recalling Superion Indirect Decompression System kits (8mm to 16mm) because the devices and instruments don't consistently meet expected performance levels, leading to breakage. This could affect surgical procedures and patient safety.
The devices and instruments have been found to break inconsistently during use, which can lead to complications in spinal surgery. This issue affects the reliability of the system and may cause surgical complications.
Medical professionals who use the Superion Indirect Decompression System kits for spinal procedures are most at risk. Patients using these systems are not directly affected as the recall applies to the medical devices.
Check the product label for the model number (8mm, 10mm, 12mm, 14mm, or 16mm Superion Indirect Decompression System) and the lot/batch numbers listed in the recall notice. The recall covers specific lot/batch numbers for each model.
Look for the model number (8mm, 10mm, 12mm, 14mm, or 16mm Superion Indirect Decompression System) and the lot/batch numbers listed in the recall notice.
Boston Scientific determined that the devices and instruments do not consistently meet expected performance levels, leading to breakage of instruments and implants.
Check the product label for the model number and lot/batch numbers. If your product matches the listed numbers, contact Boston Scientific for further instructions.
No, patients are not directly affected as this recall applies to the medical devices used by healthcare professionals during surgery.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2485-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2485-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
