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March 11, 2016: Teleflex Heart Catheter Recall Due to Risk of Fatal Blood Loss

Teleflex Heart Catheter Recall

Teleflex Incorporated of Wayne, PA, recalled its ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits as the U.S. Food and Drug Administration (FDA) branded the risk as a “Class I Recall: 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 Teleflex Heart Catheter Recall press release, the Intra-Aortic Balloon Catheter and Percutaneous Insertion Kits are inserted in the aorta and provides mechanical circulatory support for cardiac patients. This is achieved by inflating and deflating the balloon at different phases of the cardiac cycle to increase cardiac output and decrease the work of the heart.

Teleflex Heart Catheter Recall and Dangerous Adverse Effects

The Teleflex Heart Catheter Recall was initiated due to the risk of the sheath body separating from the sheath hub. If the separation of the sheath body from the sheath hub occurs, the patient may experienced bleeding.

At the time of the recall, there were 13 adverse events reported; including 6 serious injuries and 1 death. These serious injuries and death may occur if bleeding is not promptly addressed. This will lead to significant, possibly lethal, blood loss. Interruption or loss of intra-aortic balloon pump treatment may also occur, the press release explains.

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