Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated : Class I Recall - Sheath Body may become Separated from Sheath Hub

If the separation occurs, patient may bleed from the sheath. If bleeding is not promptly addressed, significant blood loss/exsanguination, interruption/loss of intra-aortic balloon pump treatment may occur.
Source: FDA MedWatch Safety Alert - Category: American Health Source Type: alerts