Exact FDA event identifier

Event 69965

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 04, 2014
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

2 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 2

ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

Z-0878-2015

Recall number: Z-0878-2015
Initiated: December 04, 2014
Classification: Class II
Status: Terminated
Recalling firm: Ev3, Inc.
Quantity: 14

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

labeling error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.

Code information

Lot # 9922452

Distribution pattern

International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.

device · product 2 of 2

ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

Z-0879-2015

Recall number: Z-0879-2015
Initiated: December 04, 2014
Classification: Class II
Status: Terminated
Recalling firm: Ev3, Inc.
Quantity: 24