- Recalling firm
- INSPIREMD Inc
- Reason for recall
- Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- Affected products (lot / model / serial)
- UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
- Units affected
- 190 units
- Distribution pattern
- US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.
- Firm location
- Miami, FL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2325-2026
- Recall initiated
- May 1, 2026
- FDA classification date
- June 5, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98922
- Last updated on HTM Vibe
- July 23, 2026