Boston Scientific recalls Superion Indirect Decompression System models 101-9808, 01-9812, and 101-9814 due to potential spindle cap weld breakage that may prevent proper device deployment during surgery.
Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.
Boston Scientific is recalling Superion Indirect Decompression System devices with specific model numbers and sizes because they may break at a critical connection point, preventing the device from working correctly during implantation. This could lead to improper treatment of the patient's condition.
The devices may experience weld breakage at the spindle cap-to-main body interface during implantation. This separation can prevent the device from deploying properly, potentially causing ineffective treatment of the patient's condition.
Surgical patients who have been implanted with the recalled Superion Indirect Decompression System models are affected. Medical professionals using these devices for procedures are also at risk.
Check the model numbers and sizes listed: 101-9808 (8mm), 01-9812 (12mm), and 101-9814 (14mm). The specific lot/batch numbers are also listed in the recall notice for each model.
Identify the model number and size from the device's label to confirm if it matches the recalled models: 101-9808 (8mm), 01-9812 (12mm), or 101-9814 (14mm).
Reach out to Boston Scientific directly for further instructions on the recall process or to confirm if your device is affected.
The recall affects Superion Indirect Decompression System models 101-9808 (8mm), 01-9812 (12mm), and 101-9814 (14mm).
The devices may experience weld breakage at the spindle cap-to-main body interface, which can prevent proper deployment during implantation.
Check the model number and size on your device to see if it matches the recalled models. Contact Boston Scientific for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0230-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0230-2023 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.
