Class II — Edwards Lifesciences, LLC
| Recalling firm | Edwards Lifesciences LLC |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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 co… |
| Quantity | 2715 units |
| Distribution | 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. |
| Initiated | 2019-01-16 |
| Classified | 2019-04-05 |
| Recall number | Z-1100-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Edwards Lifesciences, LLC (Z-1100-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81928/
Alerts for Edwards Lifesciences LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.