Recall Z-1758-2015— Edwards Lifesciences, LLC

Name: FDA recall Z-1758-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-05

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2015-05-05, terminated 2017-12-12. It names one FDA 510(k) clearance: K132175. Product: Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.. Reason: Potential device damage on the strain relief near the hub area, which may result in blood leakage..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-05-05
Terminated: 2017-12-12
Firm location: Draper, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K132175 — EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETEREdwards Lifesciences, LLC·cleared 2013-09-13

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

Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.

Reason for recall

Potential device damage on the strain relief near the hub area, which may result in blood leakage.

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