EV3 Pipeline Flex Embolization Device Recalled for Push Wire Fracture Risk
Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices due to potential push wire fractures in the delivery system during use.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which per FDA guidance indicates serious hazard potential and never goes below severity score 4. The identified push wire fracture risk in a critical delivery system component could compromise device function during use, though no illnesses or injuries have yet been reported.
Plain-English summary
Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices with Flex Shield Technology, distributed throughout the United States and internationally.
The recall is due to potential push wire fractures that may occur in the delivery system during use. These fractures develop in the spiral cut area of the Hypotube, a critical component of the device's delivery mechanism.
The FDA has classified this as a Class I recall, indicating serious hazard potential. No illnesses or injuries have been reported to date.
The recalled product
- Product
- EV3 Pipeline Flex Embolization Device with Flex Shield Technology
- Manufacturer
- Micro Therapeutics Inc,
- Affected units
- 16,169
Distribution
Part of a larger recall action
This product is one of 2 recalled by Micro Therapeutics Inc, 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 2 products in this recall →Related recalls
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