FDA Announces Teleflex and Arrow International Recall of ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage dicardiology.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from dicardiology.com Daily Mail and Mail on Sunday newspapers.
Abiomed is recalling the labeling for Impella RP Flex with Smart Assist System Catheter because the catheters’ Instructions for Use (IFU) do not appropriately address precautions for healthcare providers to take when treating patients whose anticoagulation clotting time is below the recommended value
According to a news release issued by the U.S. Food and Drug Administration (FDA), Abiomed has recalled specific Impella 5.5 with SmartAssist for purge fluid leaks that can cause pump stop and loss of support. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.