InspireMD, Inc. (NASDAQ: NSPR) announced a voluntary recall of its CGuard Prime 135 cm carotid stent delivery system. The recall is limited to the delivery system; the CGuard Prime stent implant remains in use and continues to deliver the lowest major adverse event rates and durable stroke prevention among carotid interventions.
The recall was triggered by a controlled launch in which the delivery system failed to meet the company’s technical performance expectations during carotid artery stenting procedures. Management is implementing design improvements and expects FDA approval of the revised delivery system in the first half of 2027. "Our continued strong unit sales growth worldwide in the first quarter 2026 reflects significant demand for this novel stent technology with our best‑in‑class CGuard implant. However, the controlled launch of CGuard Prime in the U.S. has revealed opportunities to improve the technical performance of the delivery system," said CEO Marvin Slosman.
In light of the temporary discontinuation of U.S. commercial activity pending FDA approval of its original CGuard stent delivery system, InspireMD has withdrawn its full‑year 2026 revenue guidance. The company had previously projected revenue in the range of $13 million to $15 million, a 45% to 65% increase over 2025. The guidance withdrawal signals a short‑term revenue impact and increased remediation costs, but the company remains confident in its long‑term growth trajectory.
Financially, InspireMD reported strong momentum in the first quarter of 2026, with global unit sales growth of 53% year‑over‑year and a 34% quarter‑over‑quarter increase in U.S. unit sales. Q4 2025 revenue was $3.1 million, up 62% year‑over‑year, and full‑year 2025 revenue was $9.0 million, up 28% year‑over‑year. Gross margin in Q4 2025 was 37.5%. While the recall may raise remediation costs, the robust demand for the stent implant and the company’s high‑margin mix help cushion the impact.
Beyond the recall, InspireMD’s product pipeline continues to advance. The original CGuard delivery system is expected to receive FDA approval in the third quarter of 2026, and the CGuard Prime 80 cm system for transcarotid artery revascularization (TCAR) is slated for approval in the second half of 2026. Additionally, the SwitchGuard neuroprotection system has received FDA approval of an investigational device exemption for its pivotal study, positioning the company for a potential commercial launch in 2027.
Investors have responded with mixed sentiment. The positive regulatory progress for SwitchGuard has been weighed against the short‑term revenue impact of the recall and guidance withdrawal. Management will provide a full company update during the Q1 2026 earnings conference call on May 4.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.