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 units were distributed internationally.
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 classified as FDA Class II, but the source text explicitly states the cause is a product labeling error and does not report any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity recall involving minor labeling errors.
Plain-English summary
Ev3, Inc. is recalling two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 and SEPX-8-6-40-135, Lot # 9922795). The recall was initiated because of a product labeling error.
The affected stent systems 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 nature of the labeling error or report any associated injuries or illnesses.
The recall involves 14 units that were distributed internationally to Russia, Romania, the United Kingdom, Germany, Italy, Spain, France, Turkey, Poland, and Japan. Healthcare providers and patients should contact Ev3, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, 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
- 14
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 # 9922452
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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