Edwards Lifesciences IntraClude Device Recall: Inter-lumen Leak Risk
Edwards Lifesciences recalls a limited number of IntraClude intra-aortic occlusion devices due to potential inter-lumen leaks between cardioplegia and pressure lumens, which could affect medical procedures.
Lower-risk 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.
Contact the company
What happened, in plain English
Edwards Lifesciences is recalling a limited number of IntraClude intra-aortic occlusion devices because some have reported leaks between the cardioplegia and pressure lumens. This could lead to complications during medical procedures if the device fails to properly isolate the aorta. Read more at govinfonow.com/recall/69113-edwards-lifesciences-intraclude-device-recall-inter-lumen-leak-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69113-edwards-lifesciences-intraclude-device-recall-inter-lumen-leak-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1100-2019
Cite this page
“Edwards Lifesciences IntraClude Device Recall: Inter-lumen Leak Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69113-edwards-lifesciences-intraclude-device-recall-inter-lumen-leak-risk. Based on FDA recall #Z-1100-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1100-2019%22&limit=1).
Why it’s dangerous
The device has three lumens: one for cardioplegia delivery, one for pressure monitoring, and one for balloon inflation. A leak between the cardioplegia and pressure lumens could cause improper blood flow monitoring or fluid management during surgery.
Who’s affected
Patients who have received the recalled IntraClude device during cardiac surgery are most at risk. Healthcare providers using the device for aortic root isolation may also be affected.
How to tell if you have this one
The recalled device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon. It was used in cardiac surgeries to occlude the aorta. Specific serial numbers are listed in the recall notice.
- Brand
Edwards Lifesciences- Category
Medical device
What to do — step by step
Check Device Serial Numbers
Look for the serial numbers listed in the recall notice (e.g., 60850886, 60850888, etc.) on the device packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this device dangerous?
The recall reports a limited number of inter-lumen leaks, but the device is generally safe. Most users do not experience issues.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1100-2019 (January 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1100-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.