CLASS II Device recall · Reported 29 Jun 2016 · FDA Enforcement Report
EverFiex" Self-expanding Peripheral Stent System recalled by Ev3
Ev3 is recalling EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, distributed nationwide in the US. The recall was initiated on 23 May 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2048-2016
- FDA event ID
- 74276
- Recalling firm
- Ev3, Plymouth, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2016
- FDA classified
- 23 Jun 2016
- Reported
- 29 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 23 May 2016 | Recall initiated by company | |
| 23 Jun 2016 | Classified by FDA | +31 days |
| 29 Jun 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide Distribution to LA and WI.
Questions about this recall
Is EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide recalled?
Yes. Ev3 recalled EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide on 23 May 2016. The recall is Class II and its status is Terminated. Recall number Z-2048-2016.
Why was it recalled?
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.
Which lots are affected?
lot: A164580
Where was it sold?
Nationwide Distribution to LA and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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