IntraClude Intra-Aortic Occlusion Device — Class I medical device recall Z-1705-2019
Terminated recall by Edwards Lifesciences, LLC, reported 2019-06-19, distributed nationwide. Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary
| Recall number | Z-1705-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2019-05-14 |
| Classified | 2019-06-11 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2024-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CO, CZ, DE, FR, GB, IT, NL, PL, RO, SE |
| Quantity | 6,552 |
| Reason classes | device malfunction |
| Model numbers | 10.5, ICF100 |
Product
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.
Reason for recall
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.
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-1705-2019. 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.