NavienTMRecalls & reported problems across all models

We found 4 models of NavienTM by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2018 and Aug 13, 2026 — classified as 1 death, 5 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (22 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 NavienTM problems

NavienTM models

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

• NavienTM RFX072-115-08MP

  CATHETER, PERCUTANEOUS
  35 reports
• NavienTM RFX058-115-08

  CATHETER, PERCUTANEOUS
  1 death14 reports
• NavienTM RFX058-125-08

  CATHETER, PERCUTANEOUS
  12 reports
• NavienTM RFX072-105-08MP

  CATHETER, PERCUTANEOUS
  6 reports

Recent NavienTM adverse event reports

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

• MalfunctionAug 13, 2026Labelling, Instructions for Use or Training Problem; Packaging Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236643 ↗
• MalfunctionApr 15, 2026Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR ANEURYSM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH UNKNOWN DIAMETER. IT WAS REPORTED THAT IMMEDIATELY AFTER TAKING THE NAVIEN CATHETER OUT, MID-SECTION DAMAGE WAS NOTICED. A NEW ONE WAS USED INSTEAD TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED. ANEURYSM CHARACTERISTICS WERE UNKNOWN. A KINK WAS OBSERVED IN THE CATHETER WHEN IT WAS REMOVED FROM THE PACKAGING. THE CAUSE OF THE DAMAGE WAS NOT DETERMINED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889127 ↗
• 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 ↗
• MalfunctionJan 29, 2026Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT UPON REMOVING THE NAVIEN CATHETER FROM ITS PACKAGING, A KINK WAS DISCOVERED IN THE DISTAL END. THE PRODUCT WAS REPLACED WITH A NEW NAVIEN CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 8 MM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE KINK WAS NOT DETERMINED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE DEVICE PACKAGING WAS NOT DAMAGED ON DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218576 ↗
• MalfunctionJan 28, 2026Difficult to Advance; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A NAVIEN WAS FOUND KINKED CAUSING THE ECHELON CATHETER DIFFICULTY TO ADVANCE. THE PATIENT WAS UNDERGOING AN ANEURYSM EMBOLIZATION. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6.8 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE OPERATOR USED A NAVIEN AND ECHELON CATHETER. AFTER THE NAVIEN CATHETER ENTERED THE BODY, RESISTANCE WAS FELT WHEN ADVANCING THE TIP, MAKING IT DIFFICULT TO POSITION. AFTER FINALLY PLACING IT, AN ECHELON MICROCATHETER COULD NOT BE ADVANCED TO THE ANEURYSM WITHIN THE NAVIEN. BOTH THE NAVIEN AND ECHELON WERE THEN WITHDRAWN TOGETHER, AND IT WAS FOUND THAT THE TIP OF THE NAVIEN WAS KINKED. THE NAVIEN WAS REPLACED WITH A NEW ONE, WHILE THE SAME ECHELON MICROCATHETER WAS USED. THIS TIME, THE ECHELON WAS ABLE TO REACH THE TARGET SMOOTHLY, AND THE PROCEDURE CONTINUED WITH COIL EMBOLIZATION. THE OPERATION WAS SUCCESSFUL, AND THE PATIENT WAS UNHARMED. 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. NO PATIENT SYMPTOMS OR FURTHER C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202786 ↗
• InjuryJan 13, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD MULTIPLE INTRACRANIAL ANEURYSMS OF THE RIGHT INTERNAL CAROTID ARTERY, INCLUDING A LARGE 10MM ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY SEGMENT AND A SMALL 4MM ANEURYSM AT THE OPHTHALMIC ARTERY SEGMENT. THE OPERATOR PLANNED TO IMPLANT A PIPELINE FOR TREATMENT. DURING THE PROCEDURE TO ESTABLISH ACCESS, IT WAS FOUND THAT THE MICROCATHETER COULD NOT ENTER THE LUMEN OF THE NAVIEN DUE TO SIGNIFICANT RESISTANCE. AFTER REPLACING WITH A NEW ONE, IT WENT THROUGH SUCCESSFULLY. THE MARKSMAN MICROCATHETER WAS POSITIONED, AND A PED-450-30 WAS DELIVERED TO THE DISTAL END OF THE MICROCATHETER. HOWEVER, THE STENT COULD NOT BE CAME OUT DESPITE BEING ABLE TO BE RETRIEVED. MULTIPLE ATTEMPTS WERE MADE WITH INCREASED PUSHING FORCE, BUT THE PROBLEM PERSISTED. SUBSEQUENTLY, POSSIBLY DUE TO REPEATED FORCEFUL MANIPULATION, THE ANEURYSM SUDDENLY RUPTURED DURING THE PROCEDURE. THE OPERATOR STATED THAT THE STENT HAD A QUALITY ISSUE AND WOULD NOT BE CHARGED FOR IT. THE DEVICE WAS STUCK (LOCKED UP) IN THE CATHETER/RESISTANCE IN THE CATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PIPELINE BECAME STUCK IN THE DISTAL SECTION OF THE C

  Patient problems: Intracranial Hemorrhage; No Clinical Signs, Symptoms or Conditions; Ruptured Aneurysm

  MAUDE report 24060650 ↗
• MalfunctionDec 17, 2025Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE OPERATOR PERFORMED A DENSE MESH FLOW-DIVERTING STENT IMPLANTATION PROCEDURE USING THE PIPELINE FLEX. THE SYSTEM WAS SUCCESSFULLY POSITIONED AND DEPLOYED BELOW TO THE T-BIFURCATION. HOWEVER, WHEN DEPLOYED IT TO THE PROXIMAL END, THE SYSTEM SLIPPED TOWARD THE PROXIMAL ASPECT OF THE ANEURYSM WHILE UNSHEATHING UNDER REDUCED TENSION. THE OPERATOR ADVANCED AN INTERMEDIATE CATHETER AND GUIDED THE SYSTEM INTO THE MIDDLE CEREBRAL ARTERY TO REDEPLOY THE STENT. NEVERTHELESS, THE STENT COULD NOT BE DEPLOYED AT THE PROXIMAL MARKER. THE SYSTEM WAS REMOVED FROM THE BODY, AND IT WAS SUSPECTED THAT THE STENT HAD BECOME STUCK WITH THE MICROCATHETER. A NEW PHENOM 27 WAS ADVANCED, AND A NEW PED-375-20 DENSE MESH FLOW-DIVERTING STENT WAS USED. IT WAS DEPLOYED SUCCESSFULLY AT THE INTENDED LOCATION, AND THE PROCEDURE WAS COMPLETED SMOOTHLY. THE PATIENT EXPERIENCED NO ADVERSE REACTIONS. THE PIPELINE BECAME STUCK AT THE HUB DURING DEPLOYMENT. THE PHYSICIAN RELEASED THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISS UE, BUT THE ISSUE DID NOT RESOLVE. CATHETER RESISTANCE IN THE DISTAL SECTION WAS REPORTED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827984 ↗
• MalfunctionDec 10, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER PUNCTURING AND PLACING THE SHEATH, THE SURGEON EXCHANGED THE SUPPORT CATHETER AND REMOVED THE RADIAL SHEATH. HE THEN USED THE SUPER-SMOOTH GUIDE WIRE TO GUIDE THE NAVIEN SUPPORT CATHETER DIRECTLY TO THE C3 SEGMENT OF THE INTERNAL CAROTID ARTERY. AFTER THE STENT MICROCATHETER WAS IN PLACE, HE PLACED THE ECHELON MICROCATHETER AND FOUND THAT THE INTERMEDIATE CATHETER COULD NOT BE DELIVERED. THE GUIDEWIRE WAS THEN WITHDRAWN AND THE ECHELON MICROCATHETER DELIVERY WAS ATTEMPTED, BUT DELIVERY WAS STILL UNSUCCESSFUL. AFTER ALL SYSTEMS WERE WITHDRAWN, IT WAS DISCOVERED THAT THE MIDDLE SECTION OF THE TERMINAL CATHETER WAS SEVERELY KINKED. THE SURGEON THEN ATTEMPTED TRANSRADIAL TREATMENT USING A HIGH-PERFORMANCE LONG SHEATH BUT WAS UNSUCCESSFUL, AND THE FEMORAL ARTERY WAS RE-PUNCTURED FOR TREATMENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE CATHETER WAS KINKED IN THE MIDDLE. THE PATIENT IS ALIVE WITH NO INJURY. THE PATIENT WAS UNDERGOING SURGERY FOR TRANSRADIAL ARTERY ANEURYSM EMBOLIZATION TREATMENT. THE ACCESS VESSEL WAS AFTER RADIAL ARTERY, FEMORAL ARTERY. IT WAS NOTED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773419 ↗
• 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 ↗
• MalfunctionNov 7, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REBAR ENCOUNTERED RESISTANCE WITH THE NAVIEN. THE CAUSE OF THE EVENT WAS NOT DETERMINED. NO RESISTANCE BETWEEN THE REBAR AND SFR. IT WAS NOT DETERMINED IF THERE WAS ANY KINK OR DAMAGE ON THE CATHETERS. NO KINK OR DAMAGE ON THE PUSHWIRE OF THE SOLITAIRE. THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497851 ↗
• MalfunctionOct 22, 2025Break; Collapse; Fracture; Physical Resistance/Sticking; Break; Collapse; Fracture; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE SMALL CRACK WAS AT THE TIP OF THE CATHETER LOCATED AT THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360405 ↗
• MalfunctionSep 2, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE CATHETER TIP BROKEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939549 ↗
• MalfunctionAug 15, 2025Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813749 ↗
• MalfunctionJul 21, 2025Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR ANEURYSM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 5.62MM DIAMETER. IT WAS REPORTED THAT DURING THE ANEURYSM SURGERY, THE SURGEON USED A NAVIEN CATHETER, THE TIP OF WHICH WAS BROKEN, AND THEN REPLACED IT WITH A CATHETER OF THE SAME MODEL TO CONTINUE THE SURGERY, AND THE PATIENT WAS FINE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556605 ↗
• MalfunctionJul 17, 2025Difficult to Advance; Unintended Movement; Difficult to Advance; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE SECTION OF THE PIPELINE FAILED TO OPEN, AND REPEATED ATTEMPTS TO RESOLVE THE ISSUE WERE UNSUCCESSFUL. SUSPECTING TWISTING OR OTHER CAUSES, THE STENT WAS WITHDRAWN AND REPLACED WITH ANOTHER STENT, WHICH RESOLVED THE PROBLEM. ADDITIONALLY, THE INTERMEDIATE CATHETER COULD NOT ADVANCE FURTHER ("UP HIGH"), AND THE SYSTEM REPEATEDLY DISENGAGED. MULTIPLE ATTEMPTS TO NAVIGATE THE BEND WERE UNSUCCESSFUL, PREVENTING FURTHER ADVANCEMENT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICES 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. THE PATIENT WAS UNDERGOING SURGERY FOR DISSECTING TREATMENT OF A FUSIFORM, UNRUPTURED RIGHT V4 DISSECTING ANEURYSM WITH A MAX DIAMETER OF 8MM AND A 6MM NECK DIAMETER. LANDING ZONE: DISTAL: 2.8MM AND PROXIMAL: 3.2MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL HAD A 10MM DIAMETER. PATIENT WAS NOTED TO HAVE A MEDICAL HISTORY OF HYPERTENSION LEVEL 2. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PRU L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538418 ↗

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