Use caution Medical device recall · FDA · Published March 30, 2018

Edwards Lifesciences IntraClude Device Recall: Possible Leak Risk

Edwards Lifesciences recalls IntraClude Intra-Aortic Occlusion Devices with possible leak at distal open end causing medical staff to add inflation fluid. Affected units include specific model numbers and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1929-2018Medical device Edwards Lifesciences ›

Use caution until it’s fixed

Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.

Take action

Contact the company

Recalling firmEdwards Lifesciences, LLC12050 S Lone Peak Pkwy · Draper, UT 84020-9414

✎ GovInfoNow plain-language explainer

Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to a possible leak at the distal open end. This leak could cause medical staff to continue adding inflation fluid to maintain balloon pressure, which may lead to complications during use. Read more at govinfonow.com/recall/71571-edwards-lifesciences-intraclude-device-recall-possible-leak-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71571-edwards-lifesciences-intraclude-device-recall-possible-leak-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1929-2018

Cite this page

“Edwards Lifesciences IntraClude Device Recall: Possible Leak Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71571-edwards-lifesciences-intraclude-device-recall-possible-leak-risk. Based on FDA recall #Z-1929-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1929-2018%22&limit=1).

The FDA announced on March 30, 2018, that Edwards Lifesciences, LLC voluntarily recalled its IntraClude Intra-Aortic Occlusion Device due to a possible leak at the distal open end of the strain relief. The recall affects 3,052 units distributed worldwide.

How to tell if you have it

Brand: Edwards Lifesciences
Product: IntraClude Intra-Aortic Occlusion Device
Model Number: ICF100
Lot Codes: 60876468, 60850885, 6060850886, 60850888, 60850889, 60850890, 60887217, 60887218, 60887219, 60887220, 60930494, 60934623, 60934624, 60934625, 60972889, 60972890, 60972892, 61014406, 61014408, 61014410, 61014411, 61050171, 61050172, 61078031, 61078032, 61097633, 61139239, 61139240, 61139241, 61139242, 61184964, 61184965, 67784966, 61184967, 61204586, 61204587, 61259626, 61259627, 61259628, and 61259629

The hazard

The device may have a possible leak at the distal open end of the strain relief. This defect causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.

Context

GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on record since July 6, 2017. Other recent recalls include the Edwards EVOQUE Tricuspid Delivery System Recall (March 27, 2026), the Edwards FEM-FLEX II Femoral Arterial Cannula Recall (May 14, 2025), and the Edwards Lifesciences TruWave Vamp Pressure Monitoring Set Recall (Oct. 4, 2023). Other recent recalls of similar products include the ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), the ICU Medical CADD Yellow Medication Cassette Reservoir Recall (Aug. 20, 2026), and the AVID Medical Halyard Arteriogram Recall (Nov. 14, 2025).

How to tell if you have this one

Check for model number ICF100 and lot numbers listed in the recall notice. The device is packaged in a sterile barrier system and used for aortic occlusion procedures.

Brand
Edwards Lifesciences
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Verify the model number (ICF100) and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 30 states, and outside the U.S.

FDA distribution: “Worldwide Distribution -- USA, to the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MI, MS, MO, NV, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV; and, the countries of to Australia, Austria, Belgium, Canada,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia.

Recall timeline

FDA terminated this recall 5.7 years after the firm started it.

Mar 30, 2018Firm started the recall
May 24, 2018FDA classified it Class II
May 30, 2018Published in FDA’s Enforcement Report
Nov 29, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How can I tell if I have the recalled device?

Check for model number ICF100 and lot numbers listed in the recall notice, including specific numbers like 60876468, 60850885, and others.

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Link to this recall

<a href="https://govinfonow.com/recall/71571-edwards-lifesciences-intraclude-device-recall-possible-leak-risk">Edwards Lifesciences IntraClude Device Recall: Possible Leak Risk (GovInfoNow)</a>

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-1929-2018 (March 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1929-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.