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FDA shares warning about stroke prevention device after injury
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Fusion42 · 28 July 2026 · Fusion42 review
The FDA issued an early warning about Boston Scientific's Enroute Transcarotid Neuroprotection System catheters after identifying a risk of arterial sheath tip separation during use, which can lead to stroke or other serious complications. At least one injury has been reported, and affected devices must be removed from clinical use and returned to the manufacturer.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
Boston Scientific's transcarotid stroke prevention device is being pulled from use due to tip separation risk. If you make a competing transcarotid system or carotid intervention tool, hospitals currently using Enroute need an alternative immediately—and they're locked in mid-procedure protocols.
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1 source · 27 Jul 2026
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