Recall Z-1055-2016— Arrow International, Inc., Division of Teleflex Medical Inc.

Name: FDA recall Z-1055-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-10

Class I · Terminated

Class I FDA medical device recall by Arrow International, Inc., Division of Teleflex Medical Inc., initiated 2016-02-10, terminated 2021-05-12. It names one FDA 510(k) clearance: K021462. Product: FiberOptix Ultra 8 IAB: 8Fr 30cc 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.. Reason: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device..

Recalling firm: Arrow International, Inc., Division of Teleflex Medical Inc.
Classification: Class I
Status: Terminated
Initiated: 2016-02-10
Terminated: 2021-05-12
Firm location: Everett, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K021462 — ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840Arrow Intl., Inc.·cleared 2002-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FiberOptix Ultra 8 IAB: 8Fr 30cc 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.