Z-0188-2018 Class II Terminated
FDA device recall Z-0188-2018 was initiated by Medtronic Inc. on November 3, 2017 and is designated Class II. Reason for recall: Stent length on the label may not match the length of the stent itself. The recall status is terminated (terminated September 1, 2020). Affected quantity: 21 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2017
- Initiation Date
- November 3, 2017
- Termination Date
- September 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
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.
Distribution Pattern
Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA
Code Information
Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328. Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301.