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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71269

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 05, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Edwards Lifesciences, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1758-2015
Recall number
Z-1758-2015
Initiated
May 05, 2015
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
3,360 units.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential device damage on the strain relief near the hub area, which may result in blood leakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.