Boston Scientific recalls Driver Instrument (REF: 102-9800) used in Superion Indirect Decompression System. Excessive force during implant may cause tip breaks, leading to metal fragments that could cause injury if not removed. MRI scans are unsafe if fragments remain.
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.
Boston Scientific is recalling Driver Instruments (REF: 102-9800) used with the Superion Indirect Decompression System. Excessive force during implant surgery can cause the instrument to break, potentially leaving metal fragments inside the body. If fragments remain, MRI scans could cause injury.
Excessive force during implant surgery can cause the driver instrument to break. If the break occurs, metal fragments may remain inside the body. MRI scans are unsafe if fragments are present due to potential injury risks.
Patients who received the Driver Instrument (REF: 102-9800) during implant surgery are affected. Surgeons and medical staff using the system are at risk during procedures.
Check for the reference number 102-9800 on the Driver Instrument. The product was sold with Superion Indirect Decompression System IFU, Superion IDS Kit IFU, and Surgical Technique Manual.
Inspect the Driver Instrument for cracks or broken tips, which may indicate a break from excessive force during implant.
Ask your surgeon if you received the recalled Driver Instrument (REF: 102-9800) during implant surgery.
The recall is due to a risk that excessive force during implant surgery may cause the driver instrument to break, potentially leaving metal fragments inside the body.
The official notice does not specify what to do if metal fragments are found inside the body.
The official notice states MRI scans are not advised if metal fragments remain in the body due to potential injury risks.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1972-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1972-2023 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.
