CLASS II ONGOING Device recall · Reported 17 Apr 2019 · FDA Enforcement Report

Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic recalled

Edwards Lifesciences is recalling Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10., triple, distributed nationwide in the US. The recall was initiated on 16 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes60850886 60850888 60850885 60850889 60850890 60876468 60760965 60887217 60887219 60887220 60934623 60887218 60934624 60930494 60934625 60972889 60972890 60972892 61014406 61014408 61014410 61014411 61050171 61050172 61078032 61078031 61097633 61139240 61139239 61139241 61139242 61184965 61184964 61184966 61184967 61204586 61204587 61259626 61259627 61259628 61259629 61288501 61369214 61369215 61369216 61369217 61425732 61425734 61425733 61495692 61517743 61495693 61531653 61531655 61704542 61531654 61704656 61713205 61713206 61713208 61713211 61713207 61713209 61713210 61713216 61713217 61713212 61713214 61713213 61713215

Quantity recalled2715 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1100-2019
FDA event ID: 81928
Recalling firm: Edwards Lifesciences, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 16 Jan 2019
FDA classified: 5 Apr 2019
Reported: 17 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

16 Jan 2019	Recall initiated by company
5 Apr 2019	Classified by FDA	+79 days
17 Apr 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, France Germany, Israel, Italy, Luxembourg, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, UAE, and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

60850886 60850888 60850885 60850889 60850890 60876468 60760965 60887217 60887219 60887220 60934623 60887218 60934624 60930494 60934625 60972889 60972890 60972892 61014406 61014408 61014410 61014411 61050171 61050172 61078032 61078031 61097633 61139240 61139239 61139241 61139242 61184965 61184964 61184966 61184967 61204586 61204587 61259626 61259627 61259628 61259629 61288501 61369214 61369215 61369216 61369217 61425732 61425734 61425733 61495692 61517743 61495693 61531653 61531655 61704542 61531654 61704656 61713205 61713206 61713208 61713211 61713207 61713209 61713210 61713216 61713217 61713212 61713214 61713213 61713215

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide

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