Class II — LeMaitre Vascular, Inc.
| Recalling firm | LEMAITRE VASCULAR, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | incorrect device size being listed on the impacted device packaging |
| 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. |
| Quantity | 62 units |
| Distribution | GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK |
| Initiated | 2019-07-24 |
| Classified | 2019-09-03 |
| Terminated | 2020-05-11 |
| Recall number | Z-2448-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — LeMaitre Vascular, Inc. (Z-2448-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83535/
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