Pipeline Flex Embolization Devices Recalled Due to Incorrect Labeling of Implant Length
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labeled implant length does not match the actual device length.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 for a labeling error regarding product dimensions, which is classified as a moderate risk under the rubric.
Plain-English summary
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices with Shield Technology (3.00 mm x 12 mm 027 REF PED2-300-12) due to incorrect labeling.
Devices labeled as 3.0 mm x 20 mm implants actually contain 12 mm implants. Conversely, devices labeled as 3.0 mm x 12 mm implants actually contain 20 mm implants.
This recall affects 13 units distributed nationwide in CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, and WA. Users should verify the actual implant length against the label.
The recalled product
- Product
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
- Manufacturer
- Micro Therapeutics, Inc.
- Hazard
- Affected units
- 11
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: 00763000448806/ Lot: D062612
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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