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Wire · opportunities

Boston Scientific's SCS leads linked to 1081 serious injuries in FDA alert

4 September 2026 · By · Wire by Fusion42

Published

4 September 2026

Topic

opportunities

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at medicaldevice-network.com →

◆ Verified

Fusion42 · 4 September 2026 · Fusion42 review

The FDA has linked Boston Scientific's spinal cord stimulation (SCS) leads to 1,081 serious injuries, raising urgent safety concerns and prompting regulatory scrutiny.

This Wire brief sits within Fusion42's coverage of Medtech.

◆ ◆ The Wire takeaway

FDA scrutiny on Boston Scientific’s spinal leads tightens market access and increases compliance costs. You need to reassess your product risk and regulatory strategy immediately.

◆ Coverage

1 source · 4 Sep 2026

◆ Related on Wire

◆ Topics

Medtechfda-alertmedical-devicesafety-issuespinal-cord-stimulationboston-scientific