Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Reason for recall: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Distribution: 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. Quantity: 147 units Lot/code info: UDI: 07290120281738; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
07290120281738
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.