Navien RFX058-115-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536000056), received between Sep 18, 2023 and Sep 3, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2024Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT A NAVIEN CATHETER WAS BROKEN IN THE SEAL PACKET. THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPARED AS INDICATION THE IFU. THE PATIENT WAS UNDERGOING COILING TREATMENT. VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY (ICA). THE ACCESS VESSEL DIAMETER WAS 5MM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DAMAGE WAS NOTICED WHILE OPENING THE INNER PACKET. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. ADDITIONAL INFORMATION RECEIVED THAT IT WAS KINKED/FRACTURED ON THE PART OF THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER WAS NOT BROKEN INTO PIECES, JUST KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125754 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT UP UNTIL AROUND MARCH 22, DAILY LIFE (SINGLE LIVING) WAS CONFIRMED; STARTING FROM MARCH 23, THE PATIENT HAD AN EPILEPTIC SEIZURE AND COULD NOT OPERATE THE SMARTPHONE (ACCORDING TO THE PATIENT). ON MARCH 27, THE MESSAGE ON LINE WAS NOT READ (USUALLY THE MESSAGE WAS READ IMMEDIATELY). ON MARCH 28, THE FAMILY MEMBER (LIVING SEPARATELY) VISITED THE PATIENT FOR A SCHEDULED VISIT TO THE DEPARTMENT AND FOUND THE PATIENT LYING NEXT TO THE BED IN AN INCONTINENT STATE. EYES OPENING TO CALL, NO UPPER EXTREMITY PARALYSIS, NO APHASIA, THERE IS DYSARTHRIA, THERE IS DISORIENTATION, BUT THE PATIENT IS SEMI-AWAKE 140/100. MRI/MRA NO ACUTE STENT OCCLUSION, THERE IS LEFT FRONTAL/PARIETAL LOBE FLAIR HIGH/DWI NEGATIVE CORTICAL LESION, AND THERE IS LEFT TEMPORAL LOBE MEDIAL LEFT THALAMUS MEDIAL FLAIR HIGH/DWI NEGATIVE CORTICAL LESION. MRI FINDINGS STRONGLY SUGGEST THAT FOREIGN-BODY GRANULOMA IS THE PRIMARY CAUSE AND THAT SYMPTOMATIC EPILEPSY DUE TO IT IS STRONGLY SUSPECTED, AND THAT THROMBOEMBOLISM SHOULD ALSO BE INVESTIGATED (ALTHOUGH IT IS A SUFFICIENT CONDITION TO BE SUSPECTED). INCREASING THE DIAGNOSTIC ACCURACY AND DIFFERENTIATING DIAGNOSIS REQUIRE CONTRAST MRI A

  Patient problems: Confusion/ Disorientation; Convulsion/Seizure; Dysphasia; Granuloma

  MAUDE report 19193724 ↗
• MalfunctionSep 18, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE REGION OF THE SUPPORT CATHETER WAS BROKEN AT THE SHAFT CENTER DUE TO STENOSIS OF THE PLAQUE AT THE INLET PART OF THE INTERNAL CAROTID ARTERY (ICA). ANOTHER SUPPORT CATHETER WAS USED AND THE SECOND SUPPORT CATHETER WAS BROKEN. SO THE PROCEDURE WAS COMPLETED. THE SUPPORT CATHETER AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE SUPPORT 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 SURGERY FOR TREATMENT OF A CEREBRAL ANEURYSM. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY (ICA) WITH A DIAMETER OF 6MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS STRONG.   ANCILLARY DEVICES INCLUDE A 8 FR RADIFOCUS SHEATH, 8F OPTIMO GUIDE CATHETER, SL-10 MICROCATHETER, AND A SYNCHRO GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770022 ↗
• MalfunctionSep 18, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE REGION OF THE SUPPORT CATHETER WAS BROKEN AT THE SHAFT CENTER DUE TO STENOSIS OF THE PLAQUE AT THE INLET PART OF THE INTERNAL CAROTID ARTERY (ICA). ANOTHER SUPPORT CATHETER WAS USED AND THE SECOND SUPPORT CATHETER WAS BROKEN. SO THE PROCEDURE WAS COMPLETED. THE SUPPORT CATHETER AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE SUPPORT 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 SURGERY FOR TREATMENT OF A CEREBRAL ANEURYSM. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY (ICA) WITH A DIAMETER OF 6MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS STRONG.   ANCILLARY DEVICES INCLUDE A 8 FR RADIFOCUS SHEATH, 8F OPTIMO GUIDE CATHETER, SL-10 MICROCATHETER, AND A SYNCHRO GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770008 ↗