Micro Therapeutics Recalls Pipeline Flex Embolization Device Due to Labeling Error
Micro Therapeutics is recalling two units of the Pipeline Flex Embolization Device with Shield Technology because the packaging label incorrectly listed the diameter as 3.00 mm when the actual unit was 2.50 mm.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding product dimensions. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are typically scored as Moderate (2).
Plain-English summary
Micro Therapeutics, Inc. is voluntarily recalling two units of the Pipeline Flex Embolization Device with Shield Technology (REF PED2-300-12, UDI-DI 00763000448806, Lot #D112860). The recall was initiated due to incorrect labeling regarding product dimensions. The packaging indicated a diameter of 3.00 mm, but the actual device unit was 2.50 mm in diameter.
The affected device is a permanent implant combined with a guidewire-based delivery system, indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms. The recall is classified as Class II by the FDA. Distribution was limited to the United States, specifically in the states of Georgia and Texas.
Healthcare providers and patients who have received this specific lot of the device should contact Micro Therapeutics, Inc. for further instructions. The discrepancy in labeling could lead to the use of an incorrect device size during a medical procedure.
The recalled product
- Product
- Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combined with a guidewire based delivery system. The Pipeline Flex Embolization…
- Manufacturer
- Micro Therapeutics, Inc.
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 2
Distribution
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