Merci Retriever Medical Devices Recalled for Expiration Date Issues
Concentric Medical Inc is recalling nine Merci Retriever devices shipped past their expiration date. The devices were labeled with the correct expiration date but distributed to US customers after that date.
What this means for you
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 illnesses, injuries, or hospitalizations. The hazard is limited to the distribution of expired devices, which fits the criteria for a moderate severity recall involving low-risk contamination or labeling/distribution errors without reported harm.
Plain-English summary
Concentric Medical Inc is recalling nine units of the Merci Retriever, a medical device intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The devices are also indicated for the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral, and coronary vasculature.
The recall was initiated because the devices were shipped to US customers past their expiration date, despite being labeled with the correct expiration date. The affected devices are Model Number 90109, Lot number 35695. Distribution included the states of Pennsylvania, California, Texas, New Mexico, and Ohio.
This is an FDA Class II recall. Patients and healthcare providers should contact their physician or the recalling firm for further instructions regarding the use of these specific devices.
The recalled product
- Product
- Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the ne
- Manufacturer
- Concentric Medical Inc
- Category
- Medical Device — Neurovascular
- Affected units
- 9
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 (2)
- Model Number 90109
- Lot number 35695
Distribution
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