ev3, Protg Rx Tapered Carotid Stent System… recallZ-0879-2015 · Ev3, Inc. · initiated Dec 4, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ev3, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Packaging process control
What the company is doing
Consignees were sent on 12/4/2014 a Covidien "Urgent Field Safety Notice" letter dated 4th December 2014. The letter described the problem and the product involved in the recall. Advised consignees to quarantine, discontinue use of the device and return the product to Covidien. They also requested consignees to complete the "Recall Verification Form" and return it to Covidien. For questions, customers can contact their local Covidien Representative.
Recall details
- Recall number
- Z-0879-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 4, 2014
- Posted by the FDA
- Dec 29, 2014
- Recalling firm
- Ev3, Inc.
- Quantity
- 24
- Product code
- NIM
- FDA submissions
- P060001
- Distribution
- International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Product description
ev3, Protg 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.
Code information (models, lots, serial numbers)
Lot # 9922795
Other devices under the same FDA submission
27 devices cleared under P060001 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Protege RX Tapered SECX-8-6-40-135Covidien LP · STENT, CAROTID22 reports
- Protege RX Tapered SECX-10-7-40-135Covidien LP · STENT, CAROTID14 reports
- Protege RX SECX-10-60-135Covidien LP · STENT, CAROTID1 death8 reports
- Protégé™ GPS™ SERB65-12-60-80Ev3, Inc · STENT, ILIAC4 reports
- Protégé™ GPS™ SERB65-10-40-120Ev3, Inc · CATHETER, BILIARY, DIAGNOSTIC3 reports
- Protégé™ GPS™ SERB65-10-40-80Ev3, Inc · CATHETER, BILIARY, DIAGNOSTIC2 reports
- Protégé™ GPS™ SERB65-10-80-120Ev3, Inc · STENT, ILIAC2 reports
- Protégé™ GPS™ SERB65-10-80-80Ev3, Inc · CATHETER, BILIARY, DIAGNOSTIC2 reports
- Protege RX SECX-9-30-135Covidien LP · STENT, CAROTID2 reports
- Protege RX SECX-9-40-135Covidien LP · STENT, CAROTID2 reports
- Protege RX SECX-10-40-135Covidien LP · STENT, CAROTID2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 69965).
- Z-0878-2015 · Terminatedev3 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 endartere…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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