Z-2048-2016 Class II Terminated
FDA device recall Z-2048-2016 was initiated by Ev3, Inc. on May 23, 2016 and is designated Class II. Reason for recall: Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Systems, model PRB35-0… The recall status is terminated (terminated September 22, 2017). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- June 29, 2016
- Initiation Date
- May 23, 2016
- Termination Date
- September 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency
Reason for Recall
Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Systems, model PRB35-08-040- 080, from lot A164580. The size on the outer box is labeled as 8x40x80mm while potentially containing a 6x40x120mm device as indicated by both the inner pouch and device labels. This potential issue is limited to two EverFiex stent system devices from lot A164580 that were repackaged by Medtronic and distributed. This does not affect any other Medtronic product or implantable devices.
Distribution Pattern
Nationwide Distribution to LA and WI.
Code Information
lot: A164580