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.
Reported: December 6, 2017 Initiated: November 3, 2017 #Z-0188-2018
Product Description
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.
Reason for Recall
Stent length on the label may not match the length of the stent itself.
Details
- Recalling Firm
- Medtronic Inc.
- Units Affected
- 21 units
- Distribution
- Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Inc.. Units affected: 21 units.
Why was this product recalled? ▼
Stent length on the label may not match the length of the stent itself.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 6, 2017. Severity: Moderate. Recall number: Z-0188-2018.
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