Pipeline Embolization Device Recalled for Missing Contraindication Information
Micro Therapeutics Inc is recalling 62 Pipeline Embolization Devices because the instructions for use are missing specific contraindications regarding pre-existing stents and medication designations.
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, but the hazard is a labeling error (missing contraindications) rather than a physical defect or contamination, fitting the criteria for minor labeling errors.
Plain-English summary
Micro Therapeutics Inc, d/b/a Ev3 Neurovascular, has initiated a recall of 62 units of the Pipeline Embolization Device (PED). The device is indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms in the internal carotid artery.
The recall was initiated because the Instructions For Use (IFU) do not include a contraindication for patients with a pre-existing stent in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from another contraindication listed in the IFU.
The affected units were distributed in the United States, including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT, and VA. Specific model and lot numbers are listed in the agency's recall record.
The recalled product
- Product
- Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophys
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 62
Distribution
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