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Boston Scientific faces FDA Class I recall for Infinion CX leads

FDA · 1 hour ago
BSX
Boston Scientific faces FDA Class I recall for Infinion CX leads
  • The FDA identified Boston Scientific's recall of unused Infinion CX Leads as its most serious recall type.
  • The recall covers unused 50 cm and 70 cm Infinion CX Lead Kits and does not affect devices already implanted.
  • Boston Scientific reported 1,081 serious injuries and no deaths associated with lead-body mechanical stress at the anchor site as of May 27, 2026.

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