Recall Database News Today

Please be aware, this recall is a correction, not a product removal.

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 

Teleflex and Arrow International recall ARROW Endurance Extended Dwell peripheral catheter system due to risk of catheter separation and leakage

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.

Arrow International, LLC, a Subsidiary of Teleflex, Inc, recalls Arrow AutoCAT 2, AC3 intra-aortic balloon pumps for unexpectedly short battery run times

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.

Arrow-Trerotola over-the-wire 7FR PTD kits are being recalled because the orange inner lumen of the catheters tip may separate from the basket causing injury.