Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated : Class I Recall - Sheath Body may become Separated from Sheath Hub

[Posted 03/11/2016]

AUDIENCE: Cardiology, Risk Manager

ISSUE: Teleflex Incorporated (NYSE: TFX) announces worldwide recall of Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits. On 9-Feb-2016, Teleflex Incorporated initiated a worldwide recall of 47,140 units distributed to hospitals, clinics, and medical centers throughout the United States and globally. The Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion 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. Interruption or loss of intra-aortic balloon pump treatment may also occur. At the time of the recall, there were 13 adverse events reported; including 6 serious injuries and 1 death.

A list of affected product codes and full list of affected lot numbers can be found in the recall notice and appendix.

BACKGROUND: The Arrow IAB is inserted in the aorta and provides mechanical circulatory support for cardiac patients, by inflating and deflating at different phases of the cardiac cycle to increase cardiac output and decrease the work of the heart.

RECOMMENDATION: Teleflex notified domestic distributors and customers via an Urgent Medical Device recall letter dated February 11, 2016. Consumers who have affected product should immediately discontinue use and return all affected product to Teleflex.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/11/2016 - Recall Notice - Teleflex Incorporated]