Navien RFX072-115-08MPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536000032), received between Nov 30, 2022 and Mar 3, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2023Difficult to Advance; Material Deformation; Physical Resistance/Sticking; Difficult to Advance; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS IN GOOD CONDITION AFTER THE OPERATION. THE VASOSPASM WAS RELIEVED BY ADJUSTING THE POSITION OF THE CATHETER, INTRAOPERATIVE ANGIOGRAPHY, ETC., AND THE OPERATION DATE WAS (B)(6) 2023. AFTER EVALUATING THE PARENT ARTERY AND ITS BRANCH VESSELS, A DENSE MESH STENT WAS CHOSEN TO BRIDGE AGAIN TO COVER THE ANEURYSM. THE OPERATION DATE WAS (B)(6) 2023. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT AND WAS BRIDGED AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE SPECIFIC CAUSE OF THE VESSEL SPASM WAS UNABLE TO BE DETERMINED.

  Patient problems: Vasoconstriction

  MAUDE report 16477707 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT REGARDING AN ALLERGY TO THE NAVIEN CATHETER. THE PATIENT WAS UNDERGOING STENT CONCOMITANT COIL EMBOLIZATION IN THE LEFT ICA. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT NAVIEN 6FR, PHENOM17 X 2, AND SCEPTER C 4MM X 10MM WERE USED DURING STENT CONCOMITANT COIL EMBOLIZATION FOR LEFT INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM. IN ADDITION, A HEADWAY21 WAS INSERTED FROM THE IPSILATERAL SIDE FOR STENTING, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH STENT COIL, BUT LATER AN ALLERGY WAS DEVELOPED. THERE WERE SEIZURES AND VISUAL HALLUCINATIONS. NO INFLAMMATION. THERE WAS A REQUEST FOR AN INVESTIGATION BECAUSE THE CATHETER'S HYDROPHILIC COATING MIGHT HAVE HAD AN EFFECT. THE PREPARATION OF THE DEVICE FOLLOWED THE INSTRUCTIONS IN THE PACKAGE INSERT. THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A HEADWAY21, PHENOM17 X 2, AND SCEPTER C 4MM X 10MM.

  Patient problems: Confusion/ Disorientation; Convulsion/Seizure

  MAUDE report 15886955 ↗