NavienTM RFX072-105-08MPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536017887), received between Dec 8, 2020 and Jul 11, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN FELT RESISTANCE WHILE NAVIGATING THE NAVIEN THROUGH A NORMAL TORTUOSITY VESSEL. AFTER TAKING OUT THE NAVIEN, IT WAS FOUND OUT THAT THE OUTER SURFACE OF NAVIEN WAS UNEVEN. 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.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE VERTEBRAL ARTERY WITH A DIAMETER OF 2.5-3.5MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719873 ↗
• MalfunctionMay 17, 2024Break; Packaging Problem; Break; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE OPERATOR OPENED THE CATHETER, HE FOUND THAT THE FRONT END OF THE CATHETER WAS BROKEN, MAKING IT UNUSABLE. AFTER REPLACING WITH THE SAME MODEL OF CATHETER DURING THE OPERATION, THE OPERATION WAS COMPLETED. 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. THERE WAS NO PATIENT INVOLVED IN THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER WAS NOT COMPLETELY SEPARATED, JUST PARTIALLY CONNECTED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE BREAK WAS LOCATED IN THE DISTAL SECTION OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340758 ↗
• MalfunctionMay 10, 2024Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE NAVIEN WAS NOT INSERTED IN THE SHUTTLE. THERE WAS CATHETER ENTRAPMENT/DIFFICULT REMOVAL IN THE DISTAL PORTION OF THE GUIDE CATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  THE PATIENT WAS UNDERGOING SURGERY FOR COILING TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286319 ↗
• MalfunctionApr 28, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT 035 WIRE HAD RESISTANCE ENCOUNTERED IN THE MIDDLE. IT WAS REPORTED THERE WAS CATHETER RESISTANCE THAT OCCURRED IN THE MIDDLE OF THE CATHETER. 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. ANCILLARY DEVICES INCLUDE A 6F SHUTTLE SHEATH, 6F NAVIEN GUIDE CATHETER, PHENOM 17 45 MICROCATHETER, AND SYNCHRO 14 GUIDEWIRE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE NAVIEN WAS DELIVERED WITH 035 WIRE. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832592 ↗
• MalfunctionFeb 8, 2023Break; Burst Container or Vessel; Break; Burst Container or Vessel

  NEW INFORMATION WAS RECEIVED. UPON INJECTION OF THE LIQUID EMBOLIC AGENT INTO THE CATHETER THERE WAS NO RESISTANCE. THE PHYSICIAN DID PAUSE DURING INJECTION OF THE LIQUID EMBOLIC AGENT FOR ABOUT 30 SECONDS. THE INJECTION RATE WAS FOLLOWED AS INDICATED IN THE COMPETITOR¿S IFU; FOLLOWED NORMAL INJECTION SPEED FOR ONYX GLUE. THE LIQUID EMBOLIC AGENT DID NOT GET EMBEDDED IN AN UNINTENDED LOCATION. THIS EVENT DID NOT REQUIRE MEDICAL INTERVENTION. THERE ARE NO IMAGES OF THE RUPTURED CATHETER AVAILABLE. THE SUBJECT IS IN NORMAL CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329063 ↗
• MalfunctionDec 8, 2020Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE CATHETER WAS KINKED IN THE MIDDLE SECTION. THE OPERATION PROCEEDED SMOOTHLY AFTER USING A REPLACEMENT PRODUCT OF THE SAME KIND. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AND FLUSHED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10973177 ↗