LeMaitre Aortic Occlusion Catheter Recalled for Incorrect Size Labeling
LeMaitre Vascular is recalling 62 units of Aortic Occlusion Catheters because the packaging lists the incorrect device size.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling error (incorrect size on packaging). Per the rubric, minor labeling errors and low-risk issues without reported injuries fall under the Moderate severity level.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 62 units of the LeMaitre Aortic Occlusion Catheter. The recall was initiated because the packaging for these specific devices lists the incorrect device size.
The affected devices are identified by Lot # OLC1051. The product is a single lumen catheter with a latex balloon, available in 28 mm or 45 mm sizes. The distribution pattern for the recalled units includes Germany, France, Slovenia, Spain, Sweden, and the UK.
Healthcare providers and patients should stop using the affected devices and contact LeMaitre Vascular, Inc. for further instructions. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- 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…
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 62
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # OLC1051
Distribution
Distribution scope not specified by the agency.
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