ev3 Pipeline Flex Embolization Device Recalled for Potential Fracture
Micro Therapeutics Inc is recalling 1,050 ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving a part 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 recall involves a structural defect in a medical device that can result in a foreign object remaining in the patient, which aligns with the rubric criteria for 'structural vehicle defect' or 'significant injury/property-damage reports' (interpreted here as significant physical harm risk from device failure).
Plain-English summary
Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling 1,050 units of the ev3 Pipeline Flex Embolization Device, which is used for neurological endovascular procedures. The recall is due to a potential defect where the device delivery system may fracture at the distal section during implantation. This fracture is caused by a weakened bond that can result in unintended separation, leaving the distal portion of the delivery system inside the patient.
The affected devices were distributed worldwide, including in the United States and numerous international markets. The recall covers specific lot numbers listed in the agency's records. 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.
Healthcare providers should stop using the affected devices and contact the manufacturer for instructions on return or replacement. Patients who have already had the device implanted do not require additional action according to the recall notice.
The recalled product
- Product
- ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Affected units
- 1,050
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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- ModerateEv3 Neurovascular Recalls Pipeline Embolization Devices Due to Incorrect Instructions
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