Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device — Class II medical device recall Z-1929-2018
Terminated recall by Edwards Lifesciences, LLC, reported 2018-05-30, distributed in AL, AZ, CA, CO, CT, FL, GA, IL…. Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation
| Recall number | Z-1929-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2018-03-30 |
| Classified | 2018-05-24 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2023-11-29 |
| Distributed | AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MI, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CO, CZ, DE, ES, FR, GB, IL, IT, LU, NL, PL, RO, SE |
| Quantity | 3,052 units |
| Reason classes | packaging, device malfunction |
| Lot numbers | 6060850886, 60850885, 60850888, 60850889, 60850890, 60876468, 60887217, 60887218, 60887219, 60887220, 60930494, 60934623, 60934624, 60934625, 60972889, 60972890, 60972892, 61014406, 61014408, 61014410, 61014411, 61050171, 61050172, 61078031, 61078032, 61097633, 61139239, 61139240, 61139241, 61139242, 61184964, 61184965, 61184967, 61204586, 61204587, 61259626, 61259627, 61259628, 61259629, 67784966 |
| Model numbers | ICF100 |
Product
Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
Reason for recall
Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.
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-1929-2018. 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.