Recall Z-1259-2015— Arrow International Inc

Name: FDA recall Z-1259-2015
Creator: U.S. Food and Drug Administration
Published: 2013-11-08

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2013-11-08, terminated 2015-03-16. It names one FDA 510(k) clearance: K021462. Product: Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS. Reason: Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Terminated: 2015-03-16
Firm location: Reading, PA, 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

Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

Reason for recall

Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.

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