Ev3 Recalls Protege Rx Tapered Carotid Stent Systems Due to Labeling Error
Ev3, Inc. is recalling two lots of Protege Rx Tapered Carotid Stent Systems due to a product labeling error. The affected devices were distributed internationally.
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 is due to a product labeling error. According to the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.
Plain-English summary
Ev3, Inc. is recalling two production lots of the Protege Rx Tapered Carotid Stent Systems. The specific lots involved are SECX-10-7-40-135 (Lot # 9922452) and SEPX-8-6-40-135 (Lot # 9922795). The recall is being conducted because of a product labeling error.
The affected devices are indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization. The source text does not specify the exact nature of the labeling error or any reported injuries or illnesses associated with the use of these devices.
The recall involves 24 units of the SEPX-8-6-40-135 model. The distribution pattern for the affected products is listed as international only, specifically to Russia, Romania, the United Kingdom, Germany, Italy, Spain, France, Turkey, Poland, and Japan. Consumers and healthcare providers should verify the lot numbers of their devices against the recalled list and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
- Manufacturer
- Ev3, Inc.
- Hazard
- Affected units
- 24
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)
- Lot # 9922795
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Ev3, 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.
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