Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device — Class II medical device recall Z-1758-2015
Terminated recall by Edwards Lifesciences, LLC, reported 2015-06-17, distributed nationwide. Potential device damage on the strain relief near the hub area, which may result in blood leakage.
| Recall number | Z-1758-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2015-05-05 |
| Classified | 2015-06-10 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2017-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 3,360 units |
| Reason classes | packaging |
| Model numbers | 10.5, ICF100 |
Product
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.
Reason for recall
Potential device damage on the strain relief near the hub area, which may result in blood leakage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1758-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.