LeMaitre Vascular, Inc. Recall: The LeMaitre Aortic Occlusion Catheter is a single lumen c
LeMaitre Vascular, Inc. Recall: The LeMaitre Aortic Occlusion Catheter is a single lumen c is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: LeMaitre Vascular, Inc.; Product: The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two ball
| Recalling firm | LeMaitre Vascular, Inc. |
|---|---|
| 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK |
| Recall initiated | 20190724 |
| Recall number | Z-2448-2019 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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