Medtronic Recalls Two EverFiex Stents Due to Outer Box Mislabeling
Medtronic is recalling two Protege EverFiex Self-expanding Peripheral Stent Systems from lot A164580 because the outer box size label may not match the device inside.
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 describes a labeling discrepancy without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic is issuing a Class II medical device recall for two Protege EverFiex Self-expanding Peripheral Stent Systems, model PRB35-08-040-080, from lot A164580. The recall is due to a potential outer box mislabeling issue where the box is labeled as 8x40x80mm but may contain a 6x40x120mm device, as indicated by the inner pouch and device labels.
This issue is limited to two specific devices that were repackaged by Medtronic and distributed nationwide to locations in Louisiana and Wisconsin. The recall does not affect any other Medtronic products or implantable devices.
Healthcare providers and facilities should check their inventory for these specific devices from lot A164580 and follow Medtronic's instructions for return or disposal. Patients who have already received these implants should contact their healthcare provider if they have concerns, although the source text does not report any adverse health consequences or injuries associated with this labeling discrepancy.
The recalled product
- Product
- EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent…
- Manufacturer
- Ev3, Inc.
- Category
- Medical Device — Vascular Stent
- Hazard
- Affected units
- 2
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: A164580
Distribution
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