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 Protege Rx Tapered Carotid Stent System, Secx-10-7-40-135, Sterile EO. 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
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 69965This product is part of a recall event; the main page for the event is Prot¿g¿ Rx Tapered Carotid Stent System, Sepx-8 recalled by Ev3.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Prot¿g¿ Rx Tapered Carotid Stent System, Sepx-8 recalled by Ev3 | Ev3 | Labeling Errors | MN |
More recalls from Ev3
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic NanoCross Elite PTA catheter recalled by ev3 | ev3 | Other | Nationwide |
| Device | CLASS I | Medtronic TurboHawk Plus Directional Atherectomy System 6F recalled | ev3 | Other | Nationwide |
| Device | CLASS I | Medtronic TurboHawk Plus Directional Atherectomy System 6F recalled | ev3 | Other | Nationwide |
| Device | CLASS I | Medtronic HawkOne Directional Atherectomy System recalled by ev3 | ev3 | Other | Nationwide |
| Device | CLASS I | Medtronic HawkOne Directional Atherectomy System recalled by ev3 | ev3 | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |