Medtronic Recalls Everflex Self-Expanding Peripheral Stents Due to Labeling Error
Medtronic is recalling 21 units of Everflex Self-Expanding Peripheral Stents because the stent length on the label may not match the actual stent 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 classified as FDA Class II, and the source text identifies the issue as a labeling discrepancy without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic Inc. is recalling 21 units of the Everflex Self-Expanding Peripheral Stent with Entrust Delivery System. The recall is due to a labeling error where the stent length indicated on the label may not match the actual length of the stent itself.
The affected devices are intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries. The specific units involved are Model No. EVD35-07-060-120 (Lot No. A476328) and Model No. EVD35-07-120-120 (Lot No. A476301).
These devices were distributed nationwide to facilities in Arizona, California, Georgia, Iowa, Illinois, Kentucky, Massachusetts, North Carolina, Nebraska, South Carolina, Tennessee, and Virginia. Healthcare providers should verify the lot numbers of their inventory and contact Medtronic for further instructions regarding the return or replacement of these units.
The recalled product
- Product
- Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries…
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Vascular Stent
- Hazard
- Affected units
- 21
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 (5)
- Model No. EVD35-07-060-120
- UDI 00821684051436
- Lot No. A476328. Model No. EVD35-07-120-120
- UDI 00821684051467
- Lot No. A476301.
Distribution
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