Recall Z-0188-2018— Medtronic Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., initiated 2017-11-03, terminated 2020-09-01. FDA's recall record names no specific 510(k) clearance for this event. 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 reference vessel diameters ranging from 4.5 - 7.5 mm.. Reason: Stent length on the label may not match the length of the stent itself..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-03
- Terminated
- 2020-09-01
- Firm location
- Plymouth, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.