Boston Scientific Corporation - AngioJet SOLENT Omni Thrombectomy Set - Class 2 Recall

AngioJet¿ SOLENT" Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized Using Ethylene Oxide. The AngioJet¿ Spiroflex¿ Thrombectomy Set is intended for: " Breaking apart and removing thrombus from infra-inguinal peripheral arteries e 2.0 mm in diameter. " Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels e 2.0mm in diameter prior to balloon angioplasty or stent placement. The AngioJet¿ SOLENT" Omni Thrombectomy Set is intended for: " Breaking apart and removing thrombus from upper and lower extremity peripheral arteries e 3.0mm in diameter, upper extremity peripheral veins e 3.0mm in diameter, ileofemoral and lower extremity veins e 3.0mm in diameter, and A-V access conduits e 3.0mm in diameter. " Use with the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The AngioJet¿ SOLENT" Dista Thrombectomy Set is intended for: " Breaking apart and removing thrombus from upper and lower extremity peripheral arteries > 1.5 mm " Use with the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The AngioJet¿ AVX¿ Thrombectomy Set is intended for use with the...
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts