Atrium Medical Recalls C-QUR V-Patch Mesh Due to Adhesion Issues
Atrium Medical Corporation is recalling C-QUR V-Patch Mesh units because the coated mesh may adhere to the inner packaging liner when exposed to high humidity.
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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a packaging/adhesion issue related to humidity, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Atrium Medical Corporation is recalling C-QUR V-Patch Mesh (all sizes and shapes), which is intended for use in soft tissue deficiencies. The recall involves 95,286 units with lot number 10405513 and higher. The product was distributed nationwide in the United States, including Puerto Rico, as well as in numerous international locations.
The recall was initiated because the coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions. This issue may affect the usability or integrity of the device during storage or handling.
Healthcare providers and facilities that have received this product should stop using it and contact Atrium Medical Corporation for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Surgical Mesh
- Hazard
- Affected units
- 95,286
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)
- Product lines with lot number 10405513 and higher
Distribution
Part of a larger recall action
This product is one of 4 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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