Recall Z-1100-2019— Edwards Lifesciences, LLC

Name: FDA recall Z-1100-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-16

Class II · Ongoing

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2019-01-16. It names one FDA 510(k) clearance: K163693. Product: Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. The large central lumen of the IntraClude Device serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring.. Reason: Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-01-16
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K163693 — IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC·cleared 2017-01-26

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(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. The large central lumen of the IntraClude Device serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring.

Reason for recall

Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.

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