Protege RXRecalls & reported problems across all models

We found 11 models of Protege RX by Covidien LP in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jun 21, 2017 and Apr 23, 2025 — classified as 1 death, 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (9 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 problems

Protege RX models

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

• Protege RX SECX-10-60-135

  STENT, CAROTID
  1 death8 reports
• Protege RX SECX-9-30-135

  STENT, CAROTID
  2 reports
• Protege RX SECX-9-40-135

  STENT, CAROTID
  2 reports
• Protege RX SECX-10-40-135

  STENT, CAROTID
  2 reports
• Protege RX SECX-8-60-135

  STENT, CAROTID
  2 reports
• Protege RX SECX-10-20-135

  STENT, CAROTID
  1 report
• Protege RX SECX-6-30-135

  STENT, CAROTID
  1 report
• Protege RX SECX-8-30-135

  STENT, CAROTID
  1 report
• Protege RX SECX-7-40-135

  STENT, CAROTID
  1 report
• Protege RX SECX-8-40-135

  STENT, CAROTID
  1 report
• Protege RX SECX-6-60-135

  STENT, CAROTID
  1 report

Recent Protege RX adverse event reports

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

• MalfunctionApr 23, 2025Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  A PHYSICIAN ATTEMPTED TO IMPLANT A PROTEGE RX STENT FOR THE TREATMENT OF A FIBROUS LESION IN THE PATIENT'S MID COMMON CAROTID ARTERY. MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WAS REPORTED. A 5MM SPIDER FX EMBOLIC PROTECTION DEVICE WAS USED. THE VESSEL WAS PRE-DILATED USING A 3.5MM DEVICE. IT WAS REPORTED THAT DURING STENT PLACEMENT, THE OUTER SHEATH WAS HARD AND COULD NOT BE PULLED OUT. IT WAS REMOVED ONCE AS IS AND A NEW ONE WAS OPENED AND INSERTED. THIS WAS ALSO HARD, BUT IT COULD BE DEPLOYED. THE FIRST ONE THAT WAS REMOVED WAS PULLED OUT SO HARD THAT IT DEPLOYED AND BROKE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889817 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE PROTÉGÉ RX CAROTID STENT WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY (L1). ON THE SAME DAY, POST PROCEDURE, THE PATIENT SUFFERED FROM A POST PROCEDURE HYPOTENSION AND BRADYCARDIA RESPONSE. THE EVENT WAS TREATED WITH MEDICATION. THE MEDICATION WAS LATER DISCONTINUED AFTER VITAL SIGNS IMPROVED. THE PATIENT WAS DISCHARGED. THE PATIENT RECOVERED.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 17323595 ↗
• MalfunctionJun 14, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED A PATIENT WAS IMPLANTED WITH AN EXPIRED PROTÉGÉ STENT 44 DAYS POST EXPIRY. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124525 ↗
• MalfunctionMay 19, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PROTÉGÉ RX WAS INTENDED TO BE USED FOR THE TREATMENT OF A LESION IN THE COMMON CAROTID ARTERY. A 6FR NON MEDTRONIC SHEATH WAS USED. THE DEVICE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE DURING DELIVERY TO THE LESION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE LOCK PIN WAS CHECKED FOR SECUREMENT. .THE LESION WAS PRE-DILATED. IT WAS REPORTED THE DEVICE WAS UNABLE TO DEPLOY. THE THUMBSCREW/LOCK-PIN WAS OPENED PRIOR TO ATTEMPTED DEPLOYMENT. NO INTERVENTION WAS NEEDED TO REMOVE THE DEVICE IT WAS REMOVED FROM THE SHEATH AND REMOVED WITHOUT INCIDENT FROM THE PATIENT. STRUTS WERE VISIBLE AFTER DEVICE WAS REMOVED FROM SHEATH. ANOTHER STENT WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960308 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE PROTÉGÉ STENT WAS USED TO TREAT THE LEFT COMMON ILIAC (L1). APPROXIMATELY 6 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM IN STENT RESTENOSIS OF THE LEFT INTERNAL CAROTID ARTERY. THE PATIENT WAS ASYMPTOMATIC. 70% OCCLUSION WAS NOTED TO THE LEFT CAROTID ARTERY ON THE FOLLOW UP DUPLEX ULTRASOUND. AN ANGIOGRAM WAS PERFORMED WHICH REVEALED 70% OCCLUSION TO THE MID STENT FROM THE ORIGINAL PROCEDURE. THE EVENT WAS TREATED WITH RE-STENTING. THE PATIENTS MEDICATION WAS ALSO ADJUSTED. THE PATIENT IS RECOVERING.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 16634371 ↗
• MalfunctionMar 9, 2023Premature Activation; Premature Activation

  A PROTÉGÉ RX SELF-EXPANDING STENT WAS INTENDED TO BE USED TO TREAT A LESION IN A PATIENT. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE STENT PRE-DEPLOYED IN THE CATHETER PRIOR TO REACHING THE TARGET LESION. THE PROCEDURE WAS COMPLETED BY REPLACING A NEW PRODUCT OF THE SAME SIZE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518559 ↗
• MalfunctionJun 30, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE RX SELF-EXPANDING STENT ALONG WITH A SPIDER FX GUIDEWIRE DURING PROCEDURE. THERE WAS NO DAMAGE TO THE PACKAGE. THERE WAS NO DEFECT WHEN REMOVING THE PRODUCT FROM THE PACKAGE OR TRAY. IT WAS REPORTED THAT WHEN PROTÉGÉ WAS DEPLOYED AT THE LESION SITE, THE GRIP WAS FIXED AND THE Y-BODY WAS INSERTED INTO THE GRIP SIDE, BUT IT COULD NOT BE DEPLOYED WITHOUT BEING TRAPPED. THERE WAS NO RESISTANCE DURING DELIVERY TO THE LESION. THE PRODUCT DID NOT PASS THROUGH AN ALREADY IMPLANTED STENT. PARTIAL EXPANSION OF THE STENT WAS REPORTED. THE SCREW OR LOCK-PIN WAS CHECKED PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14870758 ↗
• MalfunctionJun 1, 2022Use of Device Problem; Use of Device Problem

  A PHYSICIAN USED A PROTÉGÉ STENT TO TREAT A PATIENT. THE STENT HAD 6 DAYS PRIOR TO PROCEDURE. IFU WAS FOLLOWED. THE STENT WAS IN THE BODY BUT NOT DEPLOYED. THE TEAM WAS GOING TO RUN NEXT DOOR TO A DIFFERENT HOSPITAL (THEY ARE RIGHT ACROSS THE STREET FROM EACH OTHER) TO BORROW A GOOD DATED STENT. BUT THE PATIENT WAS UNSTABLE. THE PHYSICIAN DECIDED THAT USING THE RECENTLY EXPIRED STENT WAS IN THE PATIENTS BEST INTEREST. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565232 ↗
• MalfunctionMay 28, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  PHYSICIAN USED A PROTÉGÉ RX SELF-EXPANDING STENT WITH A SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 30MM PLAQUE LESION IN THE PATIENT¿S COMMON CAROTID ARTERY. ARTERY DIAMETER REPORTED AS 6MM. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). AFTER OPENING THE PACKAGING, IT IS REPORTED THE PHYSICIAN ATTEMPTED TO USE A 6X30 STENT WHICH THE BOX AND PACKAGING WAS LABELLED WITH, HOWEVER WHEN THE DEVICE WAS CHECKED THE HUB WAS LABELLED WITH 6X40. THE DEVICE WAS PREPPED WITHOUT ISSUE AND USED DESPITE THE LABELLING MISMATCH. THE PHYSICIAN ASSESSED THE DEVICE ON X-RAY AND IT LOOKED LIKE A 6X30. NO ISSUES NOTED DURING THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900462 ↗
• MalfunctionMay 7, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE RX STENT TO TREAT THE COMMON CAROTID ARTERY IN A PATIENT. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS USED. 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. THE DEVICE PREPPED PER THE IFU WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK PIN WAS REMOVED DURING IFU PREPARATION. IT IS REPORTED THE STENT WAS PARTIALLY PRE-DEPLOYED IN VIVO DURING PROCEDURE FOLLOWING IFU, SO IT COULD NOT BE USED. IT IS UNKNOWN IF INTERVENTION WAS REQUIRED TO REMOVE THE STENT FROM THE PATIENT'S VESSEL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788859 ↗
• MalfunctionNov 12, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE A PROTÉGÉ RX DURING TREATMENT OF A LESION IN THE PATIENT¿S MID COMMON CAROTID ARTERY. MODERATE VESSEL TORTUOSITY IS REPORTED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS REPORTED DURING ADVANCEMENT. THE DEVICE WAS DELIVERED TO THE TARGET LESION, BUT IT IS REPORTED DEPLOYMENT ISSUES WERE ENCOUNTERED. THE PHYSICIAN WAS HESITANT AS TO WHETHER TO CONTINUE ATTEMPTING TO DEPLOY THE DEVICE WAS THERE WAS NO SIGN THE TIP PART WOULD DEPLOY EVEN THOUGH IT WAS PULLED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND A DIFFERENT SIZED PROTÉGÉ RX WAS USED AS NONE OF THE SAME SIZE WERE AVAILABLE TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829301 ↗
• MalfunctionSep 8, 2020Use of Device Problem; Use of Device Problem

  PHYSICIAN INTENDED TO USE A PROTEGE RX CAROTID STENT WITH A 6FR NON-MEDTRONIC SHEATH AND SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 30MM PLAQUE LESION IN THE PATIENT¿S PROXIMAL COMMON CAROTID ARTERY OF REPORTED DIAMETER 8MM. SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. LESION EXHIBITED 70% STENOSIS. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE PROCEDURE WAS CARRIED OUT WITHOUT ISSUE NOTED. ON COMPLETION OF THE PROCEDURE IT WAS NOTED THE PRODUCT WAS EXPIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10501068 ↗
• MalfunctionApr 28, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  PHYSICIAN INTENDED TO USE A PROTÉGÉ RX SELF-EXPANDING STENT DURING TREATMENT OF THE PATIENT¿S CAROTID ARTERY. IT IS REPORTED THAT STENT JUMPING OCCURRED WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. THE PROTÉGÉ RX STENT WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10004337 ↗
• MalfunctionMar 9, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE A PROTEGE RX WITH A 9FR25 CM NON-MEDTRONIC SHEATH AND A 7FR200CM GUARDWIRE FOR TREATMENT. EMBOLIC PROTECTION WAS USED. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. NO DIFFICULTIES WERE EXPERIENCED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A NON-MEDTRONIC DEVICE. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PRE-DEPLOYED STENT. IT WAS REPORTED THAT UPON DEPLOYMENT ATTEMPT AT THE LESION, THE INNER SHEATH GOT STUCK TO THE OUTER SHEATH AND THE STENT WAS PARTIALLY DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9806072 ↗
• MalfunctionFeb 7, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO TREAT THE MID CAROTID ARTERY USING PROTEGE STENT. THE SHEATH WAS SO HARD THAT THE PROTEGE WHICH WAS DELIVERED BUT COULD NOT BE DEPLOYED. A NEW PRODUCT WITH THE SAME SIZE WAS USED WITHOUT ISSUES AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9680510 ↗

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