FDA Recalls Pipeline Embolization Devices Due to Coating Delamination
Micro Therapeutics Inc is recalling Pipeline Embolization Devices because PTFE coating may delaminate and enter the bloodstream.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Micro Therapeutics Inc, doing business as Ev3 Neurovascular, is recalling the Pipeline Embolization Device (Pipeline Classic). The recall involves 11,860 units distributed worldwide, including nationwide in the United States and internationally to numerous countries.
The recall was initiated because delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating entering the bloodstream. The device is indicated for the endovascular treatment of adults with large or giant widenecked intracranial aneurysms in the internal carotid artery.
The FDA has classified this recall as Class I, which is the most serious type of recall. Patients who have had this device implanted should contact their healthcare provider for guidance on monitoring and potential follow-up care.
The recalled product
- Product
- Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal…
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Neurovascular
- Affected units
- 11,860
Distribution
Part of a larger recall action
This product is one of 4 recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Micro Therapeutics Inc, Dba Ev3 Neurovascular
See all →- SevereEv3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk
FDA (Devices) · 2020-04-01
- Severeev3 Pipeline Flex Embolization Device Recalled for Potential Fracture
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- Moderateev3 TurboHawk Peripheral Plaque Excision System Recall for Incompatible Accessories
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- SevereEv3 MindFrame Capture Devices Recalled for Potential Wire Separation
FDA (Devices) · 2018-05-23
- CriticalEv3 Neurovascular Alligator Retrieval Device Recalled for Coating Defect
FDA (Devices) · 2016-11-16
Same hazard · coating delamination
See all →- CriticalDistal access catheters recalled after coating material lifting inside the lumen
FDA (Devices) · 2025-11-05
- SevereCenterline Biomedical IOPS Guidewire 2 Coating Delamination Risk
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- HighMicroVention Traxcess 7 Mini Guidewire Recalled for Coating Delamination
FDA (Devices) · 2017-09-13
- SevereEv3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires
FDA (Devices) · 2016-11-16
- SevereEv3 Neurovascular Recalls Pipeline Embolization Devices Due to Coating Defect
FDA (Devices) · 2014-04-23
Similar recalls
- SevereEv3 Neurovascular Recalls Pipeline Embolization Devices Due to Coating Defect
FDA (Devices) · 2014-04-23
- ModerateEv3 Neurovascular Recalls Pipeline Embolization Devices Due to Incorrect Instructions
FDA (Devices) · 2015-10-21
- ModeratePipeline Embolization Device Recalled for Missing Contraindication Information
FDA (Devices) · 2013-09-04
- Severeev3 Pipeline Flex Embolization Device Recalled for Potential Fracture
FDA (Devices) · 2020-04-01
- ModeratePipeline Flex Embolization Devices Recalled Due to Incorrect Labeling of Implant Length
FDA (Devices) · 2026-07-29
- SevereEv3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk
FDA (Devices) · 2020-04-01