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.
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 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…
- 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
Related recalls
Same manufacturer · Concentric Medical Inc
See all →- LowConcentric Medical Recalls One Distal Access Catheter for Distribution Error
FDA (Devices) · 2015-10-21
- ModerateConcentric Medical Recalls Trevo Pro 4 Stent Retrievers Due to Labeling Error
FDA (Devices) · 2014-12-17
- ModerateConcentric Medical Recalls Distal Access Catheters Due to Incorrect Labeling
FDA (Devices) · 2014-12-17
- HighConcentric Medical Recalls FlowGate Balloon Guide Catheters Due to Tip Collapse
FDA (Devices) · 2013-01-16
Same hazard · expired product
See all →- ModerateExpressaire Disposable Tourniquet Cuff Recalled for Incorrect Expiration Date
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateFDA Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateFDA Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateConcentric Medical Recalls Trevo Pro 4 Stent Retrievers Due to Labeling Error
FDA (Devices) · 2014-12-17
- HighMedical Thrombectomy Device Recalled for Incorrect Expiration Dates
FDA (Devices) · 2024-09-25
- HighMedical device retrieval basket labels show incorrect expiration dates
FDA (Devices) · 2022-10-19
- ModerateStryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates
FDA (Devices) · 2013-12-25
- HighHobbs Retrieval Forceps Recalled for Incorrect Expiration Dates
FDA (Devices) · 2022-10-19
- ModerateMedical Device Retrieval Basket Recalled for Incorrect Expiration Date
FDA (Devices) · 2022-10-19