Embolization devices recalled due to incorrect labeling of implant dimensions
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labels may incorrectly state the implant length.
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 for a labeling error that could lead to incorrect device usage.
Plain-English summary
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Device with Shield Technology (3.00 mm x 20 mm 027 REF PED2-300-20) due to incorrect labeling.
Devices labeled as 3.0 mm x 20 mm implants may actually contain 12 mm implants. Additionally, devices labeled as 3.0 mm x 12 mm implants may actually contain 20 mm implants.
This recall affects units with UDI 00763000448844 and Lot D062531 distributed nationwide in CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, and WA.
The recalled product
- Product
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
- Manufacturer
- Micro Therapeutics, Inc.
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00763000448844/ Lot: D062531
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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