Protege RX Tapered SECX-10-7-40-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00821684038727), received between Aug 15, 2017 and Jul 2, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (P060001); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Entrapment of Device; Difficult to Remove; Material Deformation; Entrapment of Device; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SPIDER FX AND THE STENT PROTEGE RX, A PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO COMPLICATIONS ENCOUNTERED IN THE LEFT DISTAL COMMON CAROTID ARTERY, WHICH HAD AN 80% STENOTIC PLAQUE AT THE TARGET LESION. THE PATIENT¿S VASCULAR ANATOMY WAS DESCRIBED AS SEVERELY TORTUOUS, INCLUDING ARCH ANATOMY TORTUOSITY AND A TORTUOUS INTERNAL CAROTID ARTERY. DURING THE PROCEDURE, THE SPIDER FX FILTER BECAME ENTRAPPED WITHIN THE STENT AND COULD NOT BE REMOVED ENDOVASCULARLY. THIS RESULTED IN REMOVAL DIFFICULTIES, REQUIRING A SURGICAL CUTDOWN FOR DEVICE RETRIEVAL. THE PATIENT WAS SUBSEQUENTLY TAKEN TO SURGERY FOR STENT AND SPIDER FX REMOVAL VIA CAROTID ENDARTERECTOMY. VESSEL DAMAGE WAS NOTED AS A CUTDOWN WAS PERFORMED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE THAT WAS NOT A MEDTRONIC PRODUCT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22385686 ↗
• MalfunctionJun 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  LIMITED INFORMATION REPORTED THAT THE DISTAL PART (OLIVE TIP) OF THE STENT SECX-10-7-40-135 PROTEGE RX SEPARATED DURING A PROCEDURE. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED. THE DEVICE WAS NEVER IMPLANTED, AND THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211741 ↗
• MalfunctionMar 22, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A PROTEGE RX SELF EXPANDING STENT TO TREAT A LESION. DEVICE WAS PREPPED PER IFU. PREMATURE DEPLOYMENT OCCURRED. PROCEDURE COMPLETED WITH A NEW DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959631 ↗
• MalfunctionJan 18, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A PROTEGE RX TO TREAT A LESION. IFU WAS FOLLOWED. WHILE TRYING TO DEPLOY AFTER ACCESSING LESION, THE COVER TO THE STENT CAME OFF EXPOSING THE STRUT EVEN THOUGH THE LOCK WAS NOT RELEASED. PHYSICIAN OPENED A NEW PRODUCT AND COMPLETED THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536545 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PROTEGE RX SELF-EXPANDING STENT AND SPIDER FX EMBOLIC DEVICE WERE USED DURING A PROCEDURE FOR TREATMENT OF A 10.MM PLAQUE/SOFT TISSUE LESION IN THE COMMON CAROTID ARTERY. THE VESSEL DIAMETER WAS 5.3 AND TORTUOSITY WAS MODERATE. AN 8FR SHEATH WAS USED. THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS PRE-DILATED WITH A 4MM PRE-DILATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED IMMEDIATELY AFTER PLACEMENT OF THE PROTEGE RX STENT, PLAQUE THAT COULD NOT BE CAPTURED WITH A FILTER DISPERSED DISTALLY, CAUSING A CEREBRAL INFARCTION, AND A THROMBUS/EMBOLISM. THE PATIENT'S LEFT SIDE WAS PARALYZED, AND THE PHYSICIAN IS CURRENTLY CONTINUING TREATMENT IN THE WARD. THE PARALYSIS IN THE LOWER LIMBS HAS IMPROVED SLIGHTLY, SO THE PATIENT WILL CONTINUE TO BE FOLLOWED UP. IT IS UNDERSTOOD THAT THE EVENT WAS NOT CAUSED BY A DEFECT IN THE DEVICES USED. WHEN THE COLLECTED FILTER WAS VISUALLY INSPECTED AFTER THE CASE, THE DEBRIS INSIDE THE FILTER WAS CONFIRMED, BUT THE DEBRIS THAT COULD NOT BE CAPTURED DISPERSED DISTALLY. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Embolism/Embolus; Paralysis; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 16885640 ↗
• MalfunctionJun 29, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ RX SELF-EXPANDING STENT TO TREAT A PROX CAROTID ARTERY - COMMON LESION IN A PATIENT WITH MODERATE TORTUOSITY. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT INACCURATE DELIVERY OCCURRED, THE STENT DEPLOYED IN UNINTENDED LESION SITE. THE STENT DEPLOYED IN THE PATIENT AND REMAINED IMPLANTED. THE PROTEGE WAS PRE-DEPLOYED DURING PROCEDURE. THE STENT DEPLOYED IN THE PATIENT AND REMAINED IMPLANTED IN THE PATIENT. NEW DEVICE WAS REPLACED, AND PROCEDURE WAS SUCCESSFULLY PERFORMED. THERE WAS SUFFICIENT DISTAL LANDING ZONE AND THE LESION WAS PRE-DILATED. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14849817 ↗
• MalfunctionMar 22, 2021Premature Activation; Premature Activation

  PHYSICIAN INTENDED TO USE A PROTEGE RX SELF-EXPANDING STENT WITH A SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S COMMON CAROTID ARTERY. SEVERE VESSEL CALCIFICATION IS REPORTED. THERE WAS NO DAMAGE NOTED THE PRODUCT PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. DEPLOYMENT ISSUES ARE REPORTED. THE LOCK-PIN WAS REMOVED BEFORE THE ATTEMPTED DEPLOYMENT. IT IS REPORTED THE STENT PREMATURELY DEPLOYED IN VIVO DURING DELIVERY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE STENT IS REPORTED TO BE IMPLANTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541487 ↗
• MalfunctionJan 12, 2021Premature Activation; Premature Activation

  PHYSICIAN INTENDED TO USE A PROTÉGÉ RX DURING PATIENT TREATMENT. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THE STENT PARTIALLY DEPLOYED ITSELF WHILST BEING NAVIGATED TO THE LESION INSIDE THE PATIENT DESPITE THE LOCK-PIN BEING IN PLACE. THE PHYSICIAN WAS ABLE TO REMOVE THE PRODUCT FROM THE PATIENT¿S BODY WITHOUT INTERVENTION AS THE PRODUCT WAS NOT FULLY DEPLOYED. THE DEVICE WAS REMOVED IN THE SHEATH. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153994 ↗
• MalfunctionNov 21, 2018Activation Failure; Activation Failure

  PHYSICIAN INTENDED TO USE TWO PROTÉGÉ RX DEVICES AND A SPIDER FX DEVICE DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID LEFT COMMON CAROTID ARTERY. SEVERE CALCIFICATION AND TORTUOSITY ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICES WERE PREPPED WITHOUT ISSUE. IT IS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH PROTÉGÉ RX DEVICES AND EXCESSIVE FORCE WAS REQUIRED DURING DELIVERY. IT IS REPORTED THAT THE STENT WIRE SNAPPED AND THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED USING A COMPETITOR STENT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8094132 ↗
• MalfunctionNov 21, 2018Activation Failure; Activation Failure

  PHYSICIAN INTENDED TO USE TWO PROTÉGÉ RX DEVICES AND A SPIDER FX DEVICE DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID LEFT COMMON CAROTID ARTERY. SEVERE CALCIFICATION AND TORTUOSITY ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICES WERE PREPPED WITHOUT ISSUE. IT IS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH PROTÉGÉ RX DEVICES AND EXCESSIVE FORCE WAS REQUIRED DURING DELIVERY. IT IS REPORTED THAT THE STENT WIRE SNAPPED AND THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED USING A COMPETITOR STENT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8094117 ↗
• MalfunctionJun 8, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PROTÉGÉ RX WITH A 6F GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM FOR TREATMENT OF A LESION IN THE PATIENT¿S CAROTID ARTERY. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS CARRIED OUT. IT WAS REPORTED THAT WHEN THE PHYSICIAN BEGAN DELIVERING THE PROTÉGÉ STENT, POST DELIVERY OF THE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM THE DISTAL TIP OF THE STENT DELIVERY SYSTEM(SDS) GOT CAUGHT ON THE GOLD MARKER OF THE GUARDWIRE. THE STENT FAILED TO BE DELIVERED TO THE TARGET LOCATION. THE STENT WAS REMOVED WITHOUT ANY ISSUE AND A NON-MDT DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7581478 ↗
• MalfunctionSep 22, 2017Premature Activation; Premature Activation

  THE PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE RX CAROTID STENT SYSTEM TO TREAT AN UNKNOWN LESION THAT APPEARED TO BE ¿ROUND¿ IN SHAPE. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS NOT PREDILATED. THE IFU WAS FOLLOWED DURING THE PROCEDURE AND THE DEVICE WAS TESTED PRIOR TO USE. THE LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT AS THE PHYSICIAN ATTEMPTED TO LOAD THE DEVICE ONTO THE GUIDEWIRE, THE PHYSICIAN FELT RESISTANCE AND THE CATHETER WAS STUCK ON ENTERING THE PATIENT. THE PHYSICIAN THEN REMOVED THE DEVICE FROM THE PATIENT. IT WAS REPORTED THAT ON INSPECTION AFTER REMOVAL, APPROX 3 - 5MM OF THE STENT WAS ALREADY DEPLOYED. THE PHYSICIAN REPLACED THE DEVICE AND COMPLETED THE PROCEDURE WITHOUT FURTHER COMPLICATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6887247 ↗
• MalfunctionAug 19, 2017Premature Activation; Premature Activation

  A PROTÉGÉ RX CAROTID STENT SYSTEM WAS USED ON AN UNKNOWN VESSEL. DEVICE IFU WAS FOLLOWED. IT WAS REPORTED THE CATHETER WAS POSITIONED AT THE PROCEDURE SITE AND THE STENT WAS EXPOSED BEFORE UNLOCKING. AS STENT WAS NOT COMPLETELY EXPOSED, IT WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6806236 ↗
• MalfunctionAug 15, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED A PROTÉGÉ RX CAROTID STENT SYSTEM WITH A 6F SHEATH AND NON-MEDTRONIC EMBOLIC PROTECTION DEVICE FOR TREATMENT OF A 30MM SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION THE RIGHT DISTAL- COMMON CAROTID ARTERY OF DIAMETER 8MM. LESION EXHIBITED 85% STENOSIS. DEVICE PREPPED AS PER IFU WITHOUT ISSUE. LESION WAS PRE-DILATED USING A 5MM NON-MEDTRONIC PRE-DILATION DEVICE. IT WAS REPORTED THAT THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING THE DEVICE. IT WAS REPORTED THAT POST-DEPLOYMENT, THE STENT TIP BROKE OFF WHEN PULLING THE DELIVERY CATHETER BACK THROUGH THE ¿TOUEY¿. THE COMPONENT EMBOLIZED WITHIN THE DELIVERY CATHETER. ¿TOUEY¿ AND THE SHEATH WERE REMOVED THEREBY REMOVING THE TIP COMPONENT FROM THE PATIENT. STENT WAS DEPLOYED SUCCESSFULLY SO THE CASE WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6796270 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060001. One submission often covers many models, so check the product and lot details in each record.

• Z-0879-2015 · Dec 4, 2014 · Terminated
  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 endarterect
• Z-0878-2015 · Dec 4, 2014 · Terminated
  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 endartere