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# Class 1 Recall of Arrow International Catheter Kits
- URL: https://www.fdaweb.com/class-1-recall-of-arrow-international-catheter-kits/
- Published: 2016-03-17T12:00:00.000Z
- Updated: 2026-09-15T02:44:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135125

> FDA has classified as Class 1 a recall by Arrow International of its intra-aortic balloon catheter kits and percutaneous insertion kits due to a sheath separation issue. If the separation occurs, the patient may bleed from the sheath. Interruption or loss of intra-aortic balloon pump treatment may also occur in these situations, a [recall](http://www.teleflex.com/en/investor/news/?ref=fdaweb.com) notice says. The device is inserted in the aorta and provides mechanical circulatory support for cardiac patients by inflating and deflating to increase cardiac output and decrease the work of the heart.