Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System (Material Number SR-200-NPS) due to potential arterial sheath tip separation during use. Affected units include specific lot numbers and GTIN.
Potential for arterial sheath tip separation or partial tip separation during use.
Boston Scientific is recalling its ENROUTE Transcarotid Neuroprotection System (Material Number SR-200-NPS) because there's a risk of the arterial sheath tip separating during use. This could lead to complications if the device is used without proper fixation.
The device's arterial sheath tip can separate during use, potentially causing bleeding or other complications. This separation risk occurs when the device is used in procedures that require precise movement of the sheath.
Medical professionals who use this device for transcarotid neuroprotection procedures are most at risk. Patients undergoing these procedures with the recalled device may also be affected.
Check for the Material Number SR-200-NPS on the device. Affected units have specific lot numbers listed in the recall notice, including GTIN 00811311020829.
Look for the Material Number SR-200-NPS on the device to confirm if it's affected.
The recall indicates a potential risk of arterial sheath tip separation during use, so it's recommended to check if your device is affected before use.
Check the Material Number SR-200-NPS and lot numbers listed in the recall notice to determine if your device is affected. If affected, contact Boston Scientific for further instructions.
Look for the Material Number SR-200-NPS on the device and check if your lot number is in the list provided in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2977-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2977-2026 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.
