RegulatoryMay 1, 2026, 04:06 PM
InspireMD Recalls CGuard Prime 135cm System; Withdraws 2026 Guidance
AI Summary
InspireMD announced a voluntary recall in the U.S. for its CGuard Prime 135 cm carotid stent delivery system due to performance issues, though patient safety is not impacted. Concurrent with this, the company withdrew its full year 2026 revenue guidance. Despite the recall, InspireMD reported strong Q1 2026 global unit sales growth of 53% and U.S. unit sales growth of 34%, and anticipates FDA approval for its original CGuard delivery system in Q3 2026 and CGuard Prime 80 cm for TCAR procedures in 2H 2026.
Key Highlights
- Initiated voluntary recall in the U.S. for CGuard Prime 135 cm carotid stent delivery system.
- Recall due to technical performance not meeting expectations during controlled launch.
- No implications for the safety of patients who previously received the CGuard stent.
- Global year-over-year unit sales grew 53% in Q1 2026.
- U.S. quarter-over-quarter unit sales grew 34% in Q1 2026.
- Withdrew prior full year 2026 revenue guidance.
- Anticipates FDA approval for original CGuard delivery system in Q3 2026.
- Anticipates FDA approval for CGuard Prime 80 cm for TCAR procedures in 2H 2026.