NavienTM RFX058-115-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00847536017795), received between Dec 17, 2018 and Nov 7, 2025 — classified as 1 death, 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 SUSPECTING TWISTING OR OTHER CAUSES, THE STENT WAS WITHDRAWN AND REPLACED WITH ANOTHER STENT, WHICH RESOLVED THE PROBLEM.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 ↗
• MalfunctionApr 23, 2025Break; Packaging Problem; Break; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A NAVIEN CATHETER TAIL FELL OFF PRIOR TO USE. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS UNDERGOING A DENSE MESH STENT FOR ANEURYSM TREATMENT. THE PATIENT¿S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY (5.6 MM DIAMETER). BEFORE USING THE DENSE MESH STENT TO TREAT ANEURYSMS, AFTER OPENING THE NAVIEN PACKAGE, THEY FOUND THAT A SECTION OF THE OUTER LAYER OF THE NAVIEN TAIL END HAD FALLEN OFF. THE FALLEN OUTER LAYER WAS CLEARLY VISIBLE. BASED ON THE SAFETY OF THE OPERATION, THEY CHANGED TO ANOTHER CATHETER AND THE OPERATION WENT SMOOTHLY. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890518 ↗
• DeathSep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT DEATH. THE PATIENT WAS UNDERGOING ANEURYSM TREATMENT, IMPLANTED SPRING COIL AND BLOOD FLOW DIVERSION DENSE MESH STENT. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNKNOWN ANEURYSM. ANEURYSM DIMENSIONS, BLOOD FLOW AND TORTUOSITY WAS UNKNOWN. THE CAUSE OF THE PATIENT¿S DEATH WAS UNKNOWN. IT WAS UNKNOWN IF DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS UNKNOWN. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DATE OF DEATH WAS UNKNOWN. THE CAUSE OF THE PATIENT¿S DEATH WAS UNKNOWN. NO EQUIPMENT MALFUNCTION DURING THE OPERATION WAS IDENTIFIED. IT WAS UNKNOWN IF THE PATIENT FOLLOWED THE DOCTOR'S INSTRUCTIONS AND TAKE RELEVANT MEDICATIONS AFTER THE OPERATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BEING TREATED FOR AN INTERNAL CAROTID ARTERY ANEURYSM NEAR THE INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY. THE CAUSE OF DEATH WAS UNKNOWN. THE FULL PROCEDURE, COMPLICATIONS DURING THE PROCEDURE AND WHEN THE PATIENT DIED WAS UNKNOWN. THE PO

  Patient problems: Insufficient Information; Unspecified Nervous System Problem

  MAUDE report 20216087 ↗
• MalfunctionFeb 9, 2024Loss of or Failure to Bond; Product Quality Problem; Patient-Device Incompatibility; Difficult to Advance; Material Integrity Problem; Loss of or Failure to Bond; Product Quality Problem; Patient-Device Incompatibility; Difficult to Advance; Material Integrity Problem

  MEDTRONIC RECEIVED A REPORT THAT THE NAVIEN CATHETER ENCOUNTERED RESISTANCE AND THE TIP END WAS NOT COATED. THE PATIENT WAS UNDERGOING PED EMBOLIZATION FOR TREATMENT OF AN ANEURYSM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 5.7 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN USING PIPELINE TO TREAT ANEURYSM, WHEN THE INTERMEDIATE CATHETER NAVIEN WAS PUSHED TO GO UPPER, THE RESISTANCE WAS EXTREMELY LARGE AND COULD NOT REACH THE LOCATION OF THE LESION. AFTER WITHDRAWING THE INTERMEDIATE CATHETER, IT WAS FOUND THAT THE TIP END WAS NOT COATED, SO ANOTHER INTERMEDIATE CATHETER WAS REPLACED, AND 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. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOCATION OF THE LESION WAS C6 SEGMENT ANEURYSM, THE SIZE OF THE ANEURYSM WAS 5.8×5.0, AND IT WAS A CYSTIC ANEURYSM. THERE WERE NO PARTICLES OF THE COATING SEEN IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681036 ↗
• MalfunctionFeb 2, 2024Loss of or Failure to Bond; Patient-Device Incompatibility; Material Integrity Problem; Physical Resistance/Sticking; Loss of or Failure to Bond; Patient-Device Incompatibility; Material Integrity Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE NAVIEN ENCOUNTERED RESISTANCE IN THE SHEATH AND THE COATING WAS FOUND DAMAGED UPON REMOVAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION. THE ACCESSED VESSEL IS THE FEMORAL ARTERY WITH A DIAMETER OF 6 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT ACCORDING TO THE NORMAL OPERATION, AFTER HYDRATING NAVIEN, IT WAS BROUGHT TO THE VERTEBRAL ARTERY THROUGH THE LONG SHEATH. THE PUSHING PROCESS WAS DIFFICULT. THE SURGEON DESCRIBED THE PUSHING PROCESS AS VERY ASTRINGENT AND WITH GREAT RESISTANCE. WHEN THE TUBE WAS WITHDRAWN, THE COATING WAS FOUND TO BE DAMAGED. 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 COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE PARTICLES OF THE CATHETER COATING OBSERVED TO BE FLAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632681 ↗
• MalfunctionFeb 1, 2024Break; Stretched; Break; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE NAVIEN WAS CRUSHED. THE NAVIEN AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE NAVIEN 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 SURGERY FOR TREATMENT OF INTRACRANIAL STENOSIS. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 10MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623995 ↗
• MalfunctionAug 2, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT WHEN PREPARING TO USE THE NAVIEN CATHETER, IT WAS FOUND THAT THE HUB FELL OFF. IT WAS REPORTED THERE WAS A CATHETER SEPARATION/BREAK. THE SEPARATION/BREAK WAS FOUND OUT OF PACKAGE OR DURING PREPARATION. THE PACKAGE WAS NOT DAMAGED. THE PACKAGE DID NOT SHOW EVIDENCE OF TAMPERING. THE BROKEN LOCATION WAS THE PROXIMAL SECTION OF THE CATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY. THE ACCESSED VESSEL DIAMETER WAS 6 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION RECEIVED THAT IT IS UNKNOWN IF THE DAMAGE WAS DIRECTLY OUT OF THE PACKAGE OR AFTER PREPARATION. THE ACCESSED VESSEL IS UNKNOWN. THE PATIENTS BASELINE AND POST THROMBECTOMY CONDITION SCORES (MRS, NIHSS, TICI SCORES) ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442611 ↗
• MalfunctionJun 6, 2023Break; Material Deformation; Break; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE NAVIEN CATHETER RUPTURED DURING USE. THE PATIENT WAS UNDERGOING PIPELINE PLACEMENT. THE ACCESSED VESSEL WAS THE LEFT GROIN WITH A VESSEL DIAMETER OF 3 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT CATHETER RUPTURE OCCURRED. IT WAS REPORTED THE CATHETER WAS BROKEN. THE RUPTURED LOCATION WAS THE DISTAL SECTION. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. ASIDE FROM THE RUPTURE THERE WAS NO OTHER DAMAGE TO THE CATHETER. THE INJECTION RATE IS UNKNOWN. IT WAS NOTED THE DOCTOR HAD NO TOWER OF POWER AND HE WENT BARE BACK WITH THE NAVIEN CATHETER. THE NAVIEN FRAYED THE INNER LINER IN THE BODY. THE DOCTOR WAS ABLE TO PULL IT OUT, BUT HE ONLY HAD SHORT 6F GROIN SHEATH IN. NO INTERMEDIATE AS HAD TO TAKE BENCHMARK OUT AND ENDED UP HAVING TO HOLD PRESSURE ON RIGHT GROIN AND ACCESSED LEFT. 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. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LESION WAS LOCATED IN THE CAVERNOUS INTERNAL CAROTID ARTERY AND WAS LARGE. THE CATHETER DID NOT FRACTURE INTO MULTIPLE PIECES.

  Patient problems: Insufficient Information

  MAUDE report 17072446 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD A PREVIOUSLY RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM THAT WAS COILED AND HAD A NECK REMNANT THAT HAD GROWN AND REQUIRED TREATMENT, AS WELL AS A POSTERIOR WALL COMPONENT THAT WAS UNPROTECTED BY PRIOR COILS. TH PHYSICIAN DECIDED THAT FLOW DIVERSION WAS MOST ADEQUATE TREATMENT FOR THIS CASE. HIS PLAN WAS TO PLACE THE PIPELINE DISTALLY IN IPSILATERAL (RIGHT) A2 INTO RIGHT A1. ACCESSING THE A2 WAS DIFFICULT, REQUIRING MULTIPLE ATTEMPTS WITH MULTIPLE TYPES OF WIRES. ONCE THE A2 WAS ACCESSED WITH THE WIRE, PHENOM27 WAS ADVANCED PAST THE TARGET TO BEGIN PIPELINE PLACEMENT. MEASUREMENTS WERE OBTAINED AND PED2-300-16 WAS CHOSEN BY THE PHYSICIAN TO BE OPTIMAL SIZE. THE DEVICE WAS LOADED INTO THE PHENOM27 AND DEPLOYED NORMALLY. FOLLOW UP IMAGING DISPLAYED ADEQUATE PLACEMENT AND PATENCY OF THE DEVICE. DURING RECOVERY OVERNIGHT THE PATIENT EXPERIENCED AN INTRACRANIAL HEMORRHAGE. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANTERIOR COMM

  Patient problems: Intracranial Hemorrhage

  MAUDE report 16565544 ↗
• MalfunctionSep 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE IN THE DISTAL PART OF THE NAVIEN CATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR A DENSE MESH STENT IMPLANTATION. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VES SEL WAS THE FEMORAL ARTERY, WHICH WAS 8MM IN DIAMETER. IT WAS REPORTED THAT AFTER THE NAVIEN WAS IN PLACE, THE MARKSMAN STENT CATHETER WAS DELIVERED. IT WAS FOUND THAT THE STENT CATHETER COULD NOT MOVE FORWARD IN THE NAVIEN, SO THE NAVIEN WAS REMOVED AND A NEW INTERMEDIATE CATHETER OF THE SAME TYPE WAS REPLACED. THE MARKSMAN CATHETER WAS DELIVERED SUCCESSFULLY, SO IT WAS BELIEVED THAT THE ISSUE WAS WITH THE NAVIEN CATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15471381 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT DEVELOPED A FISTULA DURING A PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR AN UNRUPTURED AMORPHOUS ANEURYSM LOCATED IN RIGHT INTERNAL CAROTID ARTERY (ICA) LANDING ZONE DISTAL 3.2MM PROXIMAL 4.7MM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PHYSICIAN ADVANCED A GUIDE CATHETER AND MICROCATHETER. A RUN WITH CONTRAST REVEALED A FISTULA THAT THE PHYSICIAN BELIEVES WAS CATHETER INDUCED. THE PHYSICIAN DECIDED TO ¿SACK¿ THE VESSEL AS THE RIGHT ICA ON IMAGING WAS BEING WELL FED FROM CONTRALATERAL FLOW. RIGHT ICA WAS SACRIFICED; THE PATIENT¿S CONTRALATERAL FLOW WAS FEEDING RIGHT CIRCULATION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: Fistula

  MAUDE report 9407258 ↗
• MalfunctionDec 17, 2018Inadequacy of Device Shape and/or Size; Packaging Problem; Inadequacy of Device Shape and/or Size; Packaging Problem

  MEDTRONIC RECEIVED REPORT THAT UPON OPENING THE PACKAGE, THE NAVIEN CATHETER WAS NOTED TO HAVE THE COATING PART OF THE TIP PEELED OFF. A NEW SUPPORT CATHETER WAS USED TO TREAT THE PATIENT. THERE ARE NO IMAGES AVAILABLE. AT THE TIME OF OPENING, THE DEVICE WAS IN A STATE OF BEING COVERED BY THE PACKAGING OF ABOUT 1CM WHICH WAS CURLED. THE NAVIEN WAS DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8169170 ↗