Ev3 Neurovascular Recalls Pipeline Embolization Devices Due to Incorrect Instructions
Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling 23 Pipeline and Pipeline Flex Embolization Devices because they were shipped with EU-version Instructions for Use.
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 hazard is a documentation error (incorrect IFU version) rather than a device defect or contamination, fitting the 'Minor labeling errors' or 'voluntary precautionary' criteria for a Moderate score.
Plain-English summary
Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling 23 units of the Pipeline and Pipeline Flex Embolization Devices. These devices are permanent implants used for the endovascular treatment of large or giant wide-necked intracranial aneurysms in adults. The recall was initiated because the devices were shipped with an EU version of the Instructions for Use (IFU) instead of the correct US version.
The affected devices were distributed to facilities in Tennessee, Kentucky, Virginia, Wisconsin, Missouri, Illinois, Utah, Oregon, and Maryland. No foreign consignees are listed. The recall covers specific model and lot numbers for both the Pipeline and Pipeline Flex devices, which are detailed in the official recall notice.
Healthcare providers and facilities should check their inventory for the specific model and lot numbers listed in the recall notice. If the devices are found, they should be removed from service and returned to the manufacturer or their authorized representative. Patients who have already had these devices implanted should contact their healthcare provider for guidance, as the recall is related to the documentation provided at the time of shipment rather than a defect in the device itself.
The recalled product
- Product
- -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided…
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 23
Distribution
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