Teleflex is recalling International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits, according to an FDA press release on Friday.
The recall is considered by the FDA as a Class 1. The FDA defines a Class 1 recall as, "A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
According to the FDA, the kits are being recalled because the sheath body may become separated from the sheath hub. If the separation occurs, the patient may bleed from the sheath. If bleeding is not promptly addressed, significant blood loss or exsanguination may occur.
There have been 13 instances incidents from the kits, which have caused six serious injuries and one death.
To see which units are recalled, check here .