Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Class I - Dangerous

🏥 Medical Devices Recalled: February 10, 2016 Arrow International, Inc., Division of Teleflex Medical Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
Batch: 18F14A0037 18F14B0040 18F14E0027 18F14F0027 18F14F0028
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Arrow International, Inc., Division of Teleflex Medical Inc.
Reason for Recall:: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.