The LeMaitre Aortic Occlusion Catheter is a single lumen catheter… — Class II medical device recall Z-2448-2019
Terminated recall by LeMaitre Vascular, Inc., reported 2019-09-11. incorrect device size being listed on the impacted device packaging
| Recall number | Z-2448-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2019-07-24 |
| Classified | 2019-09-03 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2020-05-11 |
| Countries outside the US | DE, ES, FR, GB, SE, SI |
| Quantity | 62 units |
| Lot numbers | OLC1051 |
Product
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.
Reason for recall
incorrect device size being listed on the impacted device packaging
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-2448-2019. 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.