Protege RX TaperedRecalls & reported problems across all models

We found 4 models of Protege RX Tapered by Covidien LP in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2017 and Apr 24, 2026 — classified as 12 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Protege RX Tapered problems

Protege RX Tapered models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Protege RX Tapered SECX-8-6-40-135

  STENT, CAROTID
  22 reports
• Protege RX Tapered SECX-10-7-40-135

  STENT, CAROTID
  14 reports
• Protege RX Tapered SECX-8-6-30-135

  STENT, CAROTID
  1 report
• Protege RX Tapered SECX-10-7-30-135

  STENT, CAROTID
  1 report

Recent Protege RX Tapered adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROTEGE RX STENT WAS IMPLANTED IN THE LEFT COMMON CAROTID ARTERY (MID/DISTAL) TO TREAT A PLAQUE LESION WITH 75¿80% LEFT INTERNAL CAROTID ARTERY STENOSIS. THE LESION LENGTH WAS 25 MM, THE ARTERY DIAMETER WAS 5¿7 MM, AND TORTUOSITY AND CALCIFICATION WERE MINIMAL. A TRANSIENT ISCHAEMIC ATTACK WAS REPORTED, AND MILD DYSPHASIA AND RIGHT HAND WEAKNESS WERE NOTED POST-PROCEDURE AND REMAINED PRESENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE DEVICE REMAINED IMPLANTED AND IN SERVICE.

  Patient problems: Dysphasia; Transient Ischemic Attack

  MAUDE report 24976705 ↗
• 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 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A PROTÉGÉ RX AND SPIDER FX WAS USED TO TREAT THE LEFT COMMON ILIAC. POST PROCEDURE PATIENT SUFFERED ACUTE MULTIFOCAL EMBOLIC CEREBROVASCULAR ACCIDENT. PATIENT DEVELOPED LEFT SIDED MOTOR DEFICITS WITH LEFT ARM AND LEFT LEG WEAKNESS. THIS WEAKNESS WAS REVERSED WHEN MEAN ARTERIAL PRESSURE (MAP) WAS GREATER THAN 100. LEVOPHED INITIATED TO MAINTAIN THIS PRESSURE. DEFICITS RETURNED IN THE INTENSIVE CARE UNIT. COMPUTED TOMOGRAPHY ANGIOGRAPHY - HEAD NEGATIVE FOR INTRACEREBRAL HEMORRHAGE. MAGNETIC RESONANCE IMAGING SHOWED MULTIPLE ACUTE INFARCTS INVOLVING BOTH CEREBELLAR AND CEREBRAL HEMISPHERES SUGGESTIVE FOR EMBOLIC ETIOLOGY. CONTINUED DUAL ANTIPLATELET THERAPY. PATIENT RECOVERED.

  Patient problems: Intracranial Hemorrhage; Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 22211553 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A PROTÉGÉ RX AND SPIDER FX WERE USED TO TREAT THE LEFT COMMON ILIAC. DURING PROCEDURE PATIENT SUFFERED HYPERTENSION. PATIENT EXPERIENCED EXTREMELY LABILE BLOOD PRESSURE DURING PROCEDURE WITH SYSTOLIC UP TO 220 MMHG. HYDRAL WAS ADMINISTERED AT END OF PROCEDURE AND SYSTOLIC BLOOD PRESSURE WENT DOWN TO 110 MMHG. PATIENT RECOVERED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 22179126 ↗
• MalfunctionMay 2, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PROTEGE RX DID NOT DEPLOY IN THE LESION DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. THE DEVICE WAS NEVER IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. WHEN THE DEVICE WAS REPORTED FOR EVALUATION, IT WAS NOTED THAT THE STENT PRE DEPLOYED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21948722 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A PROTEGE RX WAS USED TO TREAT THE LEFT COMMON ILIAC. APPROXIMATELY 3 MONTHS POST PROCEDURE PATIENT SUFFERED COMMON CAROTID ARTERY IMMEDIATELY PROXIMAL TO STENT STENOSIS. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21730161 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A PROTEGE RX STENT WAS USED TO TREAT THE LEFT COMMON ILIAC. APPROXIMATELY 9 MONTHS POST PROCEDURE PATIENT SUFFERED INTERNAL CAROTID ARTERY OCCLUSION. COMPUTED TOMOGRAPHY IMAGING SHOWED CAROTID ARTERY OCCLUSION. PATIENT WENT TO EMERGENCY DEPARTMENT FOR BLURRED VISION AND WEAKNESS WHICH RESOLVED. THE EVENT WAS TREATED WITH MEDICATION. PATIENT RECOVERED.

  Patient problems: Blurred Vision; Obstruction/Occlusion

  MAUDE report 21581268 ↗
• MalfunctionOct 4, 2024Malposition of Device; Malposition of Device

  IT IS REPORTED THAT DURING A PROCEDURE A GEOGRAPHIC MISS OF A PROTEGE RX STENT OCCURRED AND A POST-DILATATION PROCEDURE WAS COMPLETED WITH A NON-MEDTRONIC DEVICE DUE TO THE GEOGRAPHIC MISS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369550 ↗
• 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 ↗
• MalfunctionJun 14, 2023Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE RX SELF-EXPANDING STENT ALONG WITH A 6FR NON-MEDTRONIC (PENUMBRA NEURON MAX) SHEATH AND A 6MM SPIDER FX GUIDEWIRE/EMBOLIC PROTECTION DEVICE DURING TREATMENT OF 35MM PLAQUE LESION IN THE PATIENTS MID RIGHT COMMON CAROTID ARTERY. LITTLE VESSEL CALCIFICATION AND LITTLE VESSEL TORTUOSITY. ARTERY DIAMETER IS REPORTED AS 7MM. LESION EXHIBITED 85% STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. IT IS REPORTED THE TOP PART OF STENT DEPLOYMENT COMPLETELY UNSCREWED AND PHYSICIAN COULDN'T GET THE STENT TO DEPLOY. NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY TO LESION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE LESION WAS PRE-DILATED WITH A 5MM X 20 PRE-DILATION DEVICE. THE DEVICE DID NOT DETACH, NO INTERVENTION REQUIRED FOR REMOVAL OF THE DEVICE AND DEVICE WAS SAFELY REMOVED FROM PATIENT. NO STENT STRUTS WERE EXPOSED/VISIBLE ON DEVICE REMOVAL. PHYSICIAN REMOVED THE STENT THAT WOULDN'T DEPLOY AND INSERTED A NEW STENT OF THE SAME SIZE TO COMPLETE PROCEDURE. NO PATIENT IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125130 ↗
• InjuryMay 19, 2023Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT A PROTEGE RX FOR THE TREATMENT OF A 40MM CALCIFIED FIBROUS LESION IN THE DISTAL REGION OF THE COMMON CAROTID ARTERY. THE ARTERY WAS 6-8MM IN DIAMETER AND WAS SEVERELY TORTUOUS AND MODERATELY CALCIFIED. A 6FR NON MEDTRONIC SHEATH WAS USED. A 7MM SPIDER WAS USED FOR EMBOLIC PROTECTION. THE PROTEGE RX WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE STENT  BECAME DISLODGED AND WAS NOTED TO BE PARTIALLY DEPLOYED AT THE END OF THE NON MEDTRONIC SHEATH. A 6MM PTA BALLOON WAS INSERTED AND PINNED THE STENT AGAINST THE SHEATH/ PULLED DOWN TO THE GROIN AND THE PTA BALLOON LOST GRASP AND THE STENT WAS NOTED TO BE PARTIALLY IN COMMON FEMORAL ART IN LEFT GROIN AND PARTIALLY IN THE SUBCUTANEOUS. THE PHYSICIAN WAS ABLE TO SEE PART OF THE STENT AT THE INCISION SITE AND OPENED THE PUNCTURE SITE WITH HEMOSTATS AND PULLED THE STENT OUT OF THE BODY. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING THE DEVICE. THE PHYSICIAN RESTARTED THE PROCEDURE AND USED A NON MEDTRONIC STENT WITH A 7MM SPIDER FX.

  Patient problems: Insufficient Information

  MAUDE report 16963490 ↗
• 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 ↗
• MalfunctionNov 16, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT A PROTEGE RX SELF-EXPANDING STENT WAS INTENDED TO BE IMPLANTED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING DELIVERY STENT DISLODGEMENT OCCURRED. THE STENT DID NOT PREMATURELY DEPLOY. STENT WAS REMOVED WITH THE DELIVERY SYSTEM COMPLETELY. NO EXCESSIVE FORCE WAS USED, AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804329 ↗

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