NavienTM RFX058-125-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536017849), received between Feb 22, 2019 and Feb 11, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX THAT FAILED TO OPEN AT THE DISTAL END  AND THEN EXPERIENCED FRICTION AND DEPLOYED PREMATURELY. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF A RIGHT INTERNAL CAROTID ARTERY (R-ICA) CAVERNOUS SEGMENT UNRUPTURED AMORPHOUS GIANT THROMBOSED ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 33MM AND THE NECK DIAMETER WAS 30MM. THE DISTAL LANDING ZONE WAS 3.7MM; THE PROXIMAL LANDING ZONE WAS 4.8MM. VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED WITH NORMAL PRU LEVEL NOTED. IT WAS REPORTED THAT AFTER ACCESS WAS ESTABLISHED AND THE PHENOM 27 MICROCATHETER WAS POSITIONED, THE SURGEON MEASURE THE ENTIRE LENGTH OF THE VESSEL TO BE COVERED, WHICH WAS 60MM, WITH THE DISTAL VESSEL BEING EXTREMELY TORTUOUS. IT WAS PLANNED FOR A NON-MEDTRONIC STENT AND PIPELINE FLEX BRIDGING TREATMENT. THE LONG NON-MDT STENT WAS INITIALLY SELECTED, WHICH WAS SUCCESSFULLY DELIVERED AND DEPLOYED. AFTER THAT, CONSIDERING THE TORTUOUS VESSEL, THERE WERE CONCERNS THAT AN OVERLY LONG STENT MIGHT AFFECT PROPER DELIVERY AND POSITIONING, AND THE PROXIMAL VESSEL NEAR THE ANEURYSM NECK WAS NOT SUITABLE FOR EXCESSIVE COV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317886 ↗
• MalfunctionNov 18, 2025Material Deformation; Unintended Movement; Material Deformation; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584196 ↗
• MalfunctionDec 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A STENT ENCOUNTERED RESISTANCE IN THE NAVIEN CATHETER. THE PATIENT WAS UNDERGOING THROMBECTOMY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 8MM. IT WAS REPORTED THAT THE STENT DID NOT PASS THROUGH THE CATHETER. IT FAILED TO PASS AFTER MULTIPLE ATTEMPTS. IT WAS ABLE TO PASS AFTER CHANGING THE INTERMEDIATE CATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A MEDTRONIC GUIDEWIRE. THE CATHETER RESISTANCE OCCURRED IN THE MIDDLE SECTION. IT WAS NOTED THAT THE PUSHWIRE OR CATHETER WAS KINKED. A SFR-4-20 STENT WAS USED. ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICES WERE NOT KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20932087 ↗
• MalfunctionAug 8, 2024Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  MEDTRONIC RECEIVED A REPORT THAT THE COATING ON THE NAVIEN TIP WAS MISSING.  THE PATIENT WAS UNDERGOING STENT ASSISTED ANEURYSM TREATMENT. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 5.3 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING STENT-ASSISTED ANEURYSM EMBOLIZATION, THE MIDDLE CATHETER WAS DIFFICULT TO BE PUSHED TO GO UPPER. AFTER IT WAS WITHDRAWN, IT WAS FOUND THAT THE COATING ON THE NAVIEN TIP OF THE MIDDLE CATHETER WAS MISSING. AFTER REPLACING WITH ANOTHER CATHETER, THE OPERATION WAS SUCCESSFULLY COMPLETED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938338 ↗
• MalfunctionJun 4, 2024Patient-Device Incompatibility; Difficult to Advance; Material Integrity Problem; Patient-Device Incompatibility; Difficult to Advance; Material Integrity Problem

  MEDTRONIC RECEIVED A REPORT THAT THE NAVIEN CATHETER ENCOUNTERED DIFFICULT NAVIGATION AND WAS FOUND HAVING THE COATING MISSING FROM THE TIP.  THE PATIENT WAS UNDERGOING DENSE MESH STENT IMPLANTATION FOR TREATMENT OF AN ANEURYSM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 5.6 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN USING A DENSE MESH STENT TO TREAT ANEURYSMS, IT WAS DIFFICULT TO PUSH THE INTERMEDIATE CATHETER TO GO UPPER. AFTER SEVERAL ATTEMPTS, IT WAS STILL DIFFICULT TO GO UPPER. REMOVED THE INTERMEDIATE CATHETER AND FOUND THAT THE COATING ON THE TIP WAS MISSING. REPLACED IT WITH ANOTHER INTERMEDIATE CATHETER AND THE OPERATION WENT SMOOTHLY. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE CATHETER HAD NOT BEEN INSPECTED TO SEE IF THE COATING WAS PRESENT PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463105 ↗
• MalfunctionApr 22, 2024Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  MEDTRONIC RECEIVED REPORT THAT DURING THE PROCEDURE, IT WAS DIFFICULT TO ADVANCE THE NAVIEN INTERMEDIATE DISTAL ACCESS CATHETER UPPER DESPITE SEVERAL ATTEMPTS. IT WAS NOTED THAT THE NAVIEN CATHETER AND ALL ACCESSORY DEVICES HAD BEEN PREPARED PER THE INSTRUCTIONS FOR USE (IFU). WHEN THE CATHETER WAS WITHDRAWN, IT WAS FOUND THAT THE COATING WAS MISSING FROM THE TIP END. THE CATHETER WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT WHAT WAS UNDERGOING A COIL-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE VIA FEMORAL ACCESS. VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154586 ↗
• MalfunctionApr 22, 2024Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE DEVICE COATING WAS NOT LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153637 ↗
• MalfunctionJan 10, 2024Material Integrity Problem; Physical Resistance/Sticking; Material Integrity Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT NO COATING REMAINS IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489097 ↗
• MalfunctionNov 3, 2023Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING COIL-ASSISTED EMBOLIZATION OF ANEURYSM, WHEN PUSHING THE NAVIEN INTERMEDIATE CATHETER, THE RESISTANCE WAS EXTREMELY LARGE, AND ULTIMATELY IT COULD NOT BE RAISED. AFTER WITHDRAWN, IT WAS FOUND THAT THE TIP OF THE CATHETER WAS UNCOATED. THE INTERMEDIATE CATHETER WAS REPLACED WITH A NEW ONE, AND THE OPERATION WENT SMOOTHLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6.0MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064415 ↗
• MalfunctionMay 22, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MICRO-GUIDE WIRE NEVER CAME OUT, THERE WAS RESISTANCE. THE GUIDEWIRE WAS ABLE TO PASS THE CATHETER HUB. THERE WAS NO DAMAGE FOUND TO THE CATHETER HUB. THE GUIDEWIRE TIP WAS SLIGHTLY DEFORMED. THERE WAS NO KINK/DAMAGED FOUND ON THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976492 ↗
• MalfunctionDec 15, 2021Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010507 ↗
• InjuryFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  GOTO, S., IZUMI, T., NISHIHORI, M., ISHIDA, M., ISHIDA, T., OTAWA, M., . . . WAKABAYASHI, T. (2019). CARDIAC ARREST INDUCED BY CAROTID SINUS REFLEX ACTIVATION DURING FLOW-DIVERTER STENT DEPLOYMENT. WORLD NEUROSURGERY, 124, 22-24. DOI:10.1016/J.WNEU.2018.12.136. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF CARDIAC ARREST DURING PIPELINE FLEX IMPLANTATION. THE PATIENT WAS UNDERGOING PIPELINE IMPLANTATION IN THE RETREATMENT OF MULTIPLE ANEURYSMS IN THE INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM HAD BEEN COILED 6 MONTHS PRIOR. IT WAS REPORTED THAT DURING THE PROCEDURE, THE MARKSMAN WAS TRIAXIALITY ADVANCED THROUGH A 5-FRENCH NAVIEN. THE NAVIEN WAS PLACED IN THE CAVERNOUS SEGMENT OF THE ICA, AND THE MARKSMAN WAS THEN NAVIGATED TO THE SECOND SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PATIENT¿S BLOOD PRESSURE AND HEART RATE AT THAT TIME WERE 110/70 MM HG AND 66 BPM, RESPECTIVELY. A PIPELINE FLEX WAS INSERTED AND DEPLOYED FROM THE PROXIMAL END OF THE ICA POSTERIOR COMMUNICATING ARTERY BIFURCATION. DURING THE DEPLOYMENT, CARDIAC ARREST OCCURRED WHEN THE NAVIEN AND MARKSMAN WERE PUSHED FARTHER TO PROMOTE ADEQUATE OPENING AND APPOSITION OF THE PED AGAINST THE VESSEL WALL AND INCREASE THE NE

  Patient problems: Cardiac Arrest

  MAUDE report 8364196 ↗