CLASS II Device recall · Reported 7 Jan 2015 · FDA Enforcement Report
Protege Rx Tapered Carotid Stent System, Secx-10 recalled by Ev3
Ev3 is recalling ev3 Protege Rx Tapered Carotid Stent System, Secx-10-7-40-135, Sterile EO, distributed nationwide in the US. The recall was initiated on 4 Dec 2014 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-0878-2015
- FDA event ID
- 69965
- Recalling firm
- Ev3, Plymouth, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Dec 2014
- FDA classified
- 29 Dec 2014
- Reported
- 7 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 4 Dec 2014 | Recall initiated by company | |
| 29 Dec 2014 | Classified by FDA | +25 days |
| 7 Jan 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Questions about this recall
Is Protege Rx Tapered Carotid Stent System, Secx-10-7-40-135, Sterile EO recalled?
Yes. Ev3 recalled Protege Rx Tapered Carotid Stent System, Secx-10-7-40-135, Sterile EO on 4 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-0878-2015.
Why was it recalled?
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.
Which lots are affected?
Lot # 9922452
Where was it sold?
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
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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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |