Pipeline Flex Embolization Device Recalled for Potential Push Wire Fracture Risk
Micro Therapeutics recalls Pipeline Flex Embolization Devices for potential push wire fractures in the delivery system during use. Device fractures in the Hypotube may result in malfunction during vascular procedures.
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: FDA Class I medical device recall. The potential for push wire fractures in the delivery system presents serious risk of device malfunction during vascular interventions. FDA Class I classification indicates reasonable probability of serious harm.
Plain-English summary
The Pipeline Flex Embolization Device manufactured by Micro Therapeutics is subject to this Class I recall due to potential push wire fractures in the delivery system during use. The fracture develops in the spiral cut area of the Hypotube component.
This defect could cause device malfunction during critical vascular intervention procedures, potentially compromising treatment outcomes. Healthcare facilities and providers that have received affected devices should immediately discontinue use and contact the manufacturer or FDA for return and replacement procedures.
The recall encompasses 16,169 devices distributed across the United States and multiple countries worldwide. Affected products are identified by specific Pipeline Flex model numbers, reference designations, UDI codes, and manufacturing lot numbers listed in the FDA recall database.
Patients who may have received these devices should contact their treating physician to determine if follow-up evaluation is needed.
The recalled product
- Product
- Pipeline Flex Embolization Device
- 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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