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.
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 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, multi
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 23
Distribution
Related recalls
Same manufacturer · Micro Therapeutics Inc, Dba Ev3 Neurovascular
See all →- Severeev3 Pipeline Flex Embolization Device Recalled for Potential Fracture
FDA (Devices) · 2020-04-01
- HighEv3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk
FDA (Devices) · 2020-04-01
- Moderateev3 TurboHawk Peripheral Plaque Excision System Recall for Incompatible Accessories
FDA (Devices) · 2018-09-19
- HighEv3 MindFrame Capture Devices Recalled for Potential Wire Separation
FDA (Devices) · 2018-05-23
- HighEv3 Neurovascular Recalls Marathon and UltraFlow Micro Catheters
FDA (Devices) · 2016-11-16
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02