Use caution Medical device recall · FDA · Published May 14, 2019

Edwards Lifesciences IntraClude Device Recall: Balloon Rupture Risk During Surgery

Edwards Lifesciences recalls IntraClude intra-aortic occlusion devices due to potential balloon rupture during cardiopulmonary bypass, risking heart complications and requiring surgical changes.

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

🇺🇸 FDA recall #Z-1705-2019Medical device Edwards Lifesciences ›

Use caution until it’s fixed

Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.

Take action

Contact the company

Recalling firmEdwards Lifesciences, LLC1 Edwards Way · Irvine, CA 92614-5688

✎ GovInfoNow plain-language explainer

Edwards Lifesciences is recalling IntraClude intra-aortic occlusion devices that could rupture during surgery, potentially causing heart complications and requiring surgical changes. This recall affects medical devices used in specific heart surgeries. Read more at govinfonow.com/recall/67925-edwards-lifesciences-intraclude-device-recall-balloon-rupture-risk-during-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/67925-edwards-lifesciences-intraclude-device-recall-balloon-rupture-risk-during-surgery · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1705-2019

Cite this page

“Edwards Lifesciences IntraClude Device Recall: Balloon Rupture Risk During Surgery.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67925-edwards-lifesciences-intraclude-device-recall-balloon-rupture-risk-during-surgery. Based on FDA recall #Z-1705-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1705-2019%22&limit=1).

Edwards Lifesciences, LLC recalled the IntraClude intra-aortic occlusion device on May 14, 2019, according to the FDA. The recall addresses the possibility of balloon rupture during cardiopulmonary bypass.

How to tell if you have it

Brand: Edwards Lifesciences
Product: IntraClude Intra-Aortic Occlusion Device
REF: ICF100
Size: 10.5 Fr (3.5 mm) X 39.4" (100 cm)
Lot codes: All lot numbers

The hazard

If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, and the operative site may be obscured. The device would need to be exchanged or the operative strategy changed, including placement of an external cross-clamp or conversion to an open procedure.

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 Erbe Flexible Cryoprobe Recall (Feb. 12, 2026), the Merit Medical Allwell Angioplasty Pack Recall (Dec. 4, 2025), and the Datascope Cardiosave Rescue Intra-Aortic Balloon Pump Recall (Nov. 4, 2025).

How to tell if you have this one

The device is labeled as IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO. It was sold for prescription use in heart surgeries.

Brand
Edwards Lifesciences
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Label
Look for the product name, reference number ICF100, and size 10.5 Fr (3.5 mm) X 39.4" (100 cm) on the device packaging or label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 33 states.

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

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

Recall timeline

FDA terminated this recall 4.9 years after the firm started it.

May 14, 2019Firm started the recall
Jun 11, 2019FDA classified it Class I
Jun 19, 2019Published in FDA’s Enforcement Report
Apr 23, 2024FDA terminated the recall

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

Similar recalls

Latest medical device recalls

Keep exploring

More Edwards Lifesciences recalls

Link to this recall

<a href="https://govinfonow.com/recall/67925-edwards-lifesciences-intraclude-device-recall-balloon-rupture-risk-during-surgery">Edwards Lifesciences IntraClude Device Recall: Balloon Rupture Risk During Surgery (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-1705-2019 (May 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1705-2019 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.