The FDA has posted 6 enforcement recalls from Inspiremd INC since 2025, none of them Class I (most serious). Most recent report: Jun 17, 2026.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Firm name as filed with the FDA: “INSPIREMD Inc”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.