Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System Plus (Material Number SR-250-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 Plus catheter (Material Number SR-250-NPS) because it may separate during use, potentially causing complications. This recall affects medical devices used in certain surgical procedures.
The catheter's tip may separate during use, which could lead to arterial damage or other complications. This separation risk occurs under normal surgical conditions, but the exact mechanism is not fully specified in the recall.
Medical professionals who use this device for transcarotid procedures are most at risk. Patients undergoing surgery with this device may be affected if they have the recalled model.
Check for Material Number SR-250-NPS on the device. Affected units include specific lot numbers listed in the recall and GTIN 00811311021062.
Look for Material Number SR-250-NPS and the listed lot numbers on the device.
The device may experience arterial sheath tip separation during use, which could lead to complications.
Check for Material Number SR-250-NPS and the listed lot numbers (e.g., 305737, 305738, etc.) on the device.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2978-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2978-2026 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.
