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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74276

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 23, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ev3, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2048-2016
Recall number
Z-2048-2016
Initiated
May 23, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ev3, Inc.
Quantity
2

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

lot: A164580

Distribution pattern

Nationwide Distribution to LA and WI.