Reported Dec 6, 2017 · Terminated
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the…
Medtronic Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc. · 4600 Nathan Ln N · Plymouth, MN · 55442-2890
Is this the product you have?
- 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 reference vessel diameters ranging from 4.5 - 7.5 mm.
- Lot codes and dates
Model No. EVD35-07-060-120UDI 00821684051436Lot No. A476328. Model No. EVD35-07-120-120UDI 00821684051467Lot No. A476301
- Amount recalled
- 21 units
Where it was sold
Why it was recalled
Stent length on the label may not match the length of the stent itself.
This product could cause temporary or reversible health problems — stop using it.
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