Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Entries Tagged as 'FDA Alerts'
Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall
March 11th, 2010 · No Comments
Tags: FDA · FDA Alerts
Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures
March 11th, 2010 · No Comments
FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.
Tags: FDA · FDA Alerts
Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall
March 11th, 2010 · No Comments
Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.
Tags: FDA · FDA Alerts
Abiomed AB5000 Circulatory Support System: Class I Recall
March 10th, 2010 · No Comments
Device computer may shut down without an alarm, which can lead to serious injuries or death.
Tags: FDA · FDA Alerts
WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis
March 10th, 2010 · No Comments
Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.
Tags: FDA · FDA Alerts