Ev3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk
Micro Therapeutics is recalling 762 Ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving parts in the patient.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a…"
Plain-English summary
Micro Therapeutics Inc, d/b/a Ev3 Neurovascular, is recalling 762 units of the Ev3 Pipeline Flex Embolization Device with Shield Technology. The device is used for neurological endovascular procedures and was distributed worldwide, including in the United States and numerous international markets.
The recall is due to a potential defect where the delivery system may fracture at the distal section during device implantation. A weakened bond could cause unintended separation, resulting in the distal portion of the delivery system remaining in the patient. The source text notes that if a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
No specific instructions for consumers or healthcare providers are provided in the source text beyond the description of the defect and the risk profile for successfully implanted devices.
The recalled product
- Product
- ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Affected units
- 762
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same manufacturer · Micro Therapeutics Inc, Dba Ev3 Neurovascular
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Similar recalls
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