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.
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 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 with
- 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
Related recalls
Same manufacturer · Medtronic Inc.
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateKidney tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighSmartSync Patient Connector limited the window to abort high voltage therapy
FDA (Devices) · 2025-07-30
- HighCareLink SmartSync limited the window to abort a high voltage therapy
FDA (Devices) · 2025-07-30
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02