March 14, 2016 — After reports of one death and more than a dozen adverse events, Teleflex Incorporated has recalled ARROW® Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits.
The catheter is inserted into the aorta of heart surgery patients, where it provides mechanical circulatory support. The balloon inflates and deflates during the heartbeat to increase cardiac output and decrease the work-load on the heart.
The problem is that the sheath body can become separated from the sheath hub. According to the recall:
“If the separation occurs, the patient may bleed from the sheath. If bleeding is not promptly addressed, significant blood loss or exsanguination may occur. Interruption or loss of intra-aortic balloon pump treatment may also occur.”
The recall was issued after 13 adverse events were reported, including six serious injuries and one death.
On February 9, Teleflex initiated a worldwide recall of 47,140 products distributed to hospitals and clinics. The company notified distributors and customers on February 11. The FDA classified the recall as Class I, which means the agency believes there is a reasonable probability that use of the device can cause serious injury or death.
Product codes included in the recall:
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