CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report

IntraClude Intra-Aortic Occlusion Device recalled

Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Device, distributed nationwide in the US. The recall was initiated on 5 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots within expiration. 59443555 59613944 59655681 59718185 59751955 59829691 59913251 59973802 59473497 59613945 59655682 59718186 59757492 59829692 59914824 59973803 59478792 59630641 59655683 59718187 59767963 59842135 59914825 59979641 59478793 59644480 59677638 59721969 59790316 59853386 59914826 59979642 59490124 59644481 59695842 59721970 59790317 59853387 59936991 59999093 59523568 59644482 59695843 59721971 59801106 59856575 59936992 60016315 59559537 59649627 59695844 59734231 59801107 59872381 59962951 60031031 59585111 59649628 59718182 59734232 59806707 59895500 59962952 59597667 59655679 59718183 59751953 59812135 59901268 59962953 59598246 59655680 59718184 59751954 59824839 59904370 59967598

Quantity recalled3,360 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-1758-2015
FDA event ID: 71269
Recalling firm: Edwards Lifesciences, Draper, UT
Classification: Class II
Status: Terminated
Recall initiated: 5 May 2015
FDA classified: 10 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

5 May 2015	Recall initiated by company
10 Jun 2015	Classified by FDA	+36 days
17 Jun 2015	Published in enforcement report	+7 days

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

Reason for recall

Potential device damage on the strain relief near the hub area, which may result in blood leakage.

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 IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.

Where it was distributed

Nationwide Distribution -- US, including the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.

Nationwide Alabama Arizona California Colorado Connecticut Florida Georgia Idaho Illinois Kentucky Louisiana Massachusetts Maine Michigan Missouri Mississippi North Carolina Nebraska New Jersey New York

Questions about this recall

Why was it recalled?

Potential device damage on the strain relief near the hub area, which may result in blood leakage.

Which lots are affected?

All lots within expiration. 59443555 59613944 59655681 59718185 59751955 59829691 59913251 59973802 59473497 59613945 59655682 59718186 59757492 59829692 59914824 59973803 59478792 59630641 59655683 59718187 59767963 59842135 59914825 59979641 59478793 59644480 59677638 59721969 59790316 59853386 59914826 59979642 59490124 59644481 59695842 59721970 59790317 59853387 59936991 59999093 59523568 59644482 59695843 59721971 59801106 59856575 59936992 60016315 59559537 59649627 59695844 59734231 59801107 59872381 59962951 60031031 59585111 59649628 59718182 59734232 59806707 59895500 59962952 59597667 59655679 59718183 59751953 59812135 59901268 59962953 59598246 59655680 59718184 59751954 59824839 59904370 59967598

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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