INSPIREMD Inc recalls CGuard¿ Prime Carotid Stent System
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–8 of 8 recalls
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.
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob.…
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidew…