March 14, 2016 — After receiving reports of six serious injuries and one death, a recall has been issued for ARROW® Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits.
The kits are used in heart surgery patients to decrease the work-load on the heart and increase the amount of blood pumped into the body. The catheter is inserted into the aorta and the balloon is inflated and deflated along with the heartbeat.
The manufacturer has received 13 reports of adverse events. The problem is that the sheath body can separate from the sheath hub, which could cause a patient to bleed to death. 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.”
Teleflex Incorporated, the Pennsylvania-based manufacturer, initiated the recall on February 9 and sent letters to customers on February 11. The FDA deemed the action a Class I recall — the most serious type of recall, reserved for devices the agency believes pose a reasonable probability of causing severe injury or death.
Recalled product codes include:
- IAB-05830-LWS
- IAB-05830-U
- IAB-05840-LWS
- IAB-05840-U
- IAB-06830-U
- IAB-06840-U
- IAB-S730C
- IAK-06845
- IAK-S7IT
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