Neuron PNML6F088804-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948022379), received between May 18, 2021 and Jul 6, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2023Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE BASILAR ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, UPON INSERTING THE NEURON MAX INTO THE SHEATH, THE HOSPITAL TECHNOLOGIST NOTICED THAT THERE WAS BLOOD LEAKING AROUND THE HUB OF THE NEURON MAX. NEXT, UPON FURTHER INSPECTION, THE HOSPITAL TECHNOLOGIST NOTICED THE HUB OF THE NEURON MAX WAS CRACKED. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17275450 ↗
• MalfunctionJun 23, 2023Break; Unraveled Material; Break; Unraveled Material

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE INJECTING CONTRAST THROUGH THE NEURON MAX, THE PHYSICIAN NOTICED THE NEURON MAX HAD UNRAVELED AT THE HUB. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195042 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA)/ MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND PENUMBRA SMART COILS (SMART COILS). IT WAS REPORTED THE PATIENT HAD BEEN PREVIOUSLY TREATED FOR ANEURYSMS. DURING THE PROCEDURE, THE NEURON MAX WAS PLACED INTO THE CERVICAL RIGHT INTERNAL CAROTID ARTERY (ICA) USING THE ROADMAP TECHNIQUE, DOUBLE FLUSHED AND CONNECTED TO A CONTINUOUS HEPARINIZED SALINE INFUSION. THE PATIENT HAD MULTIPLE VASOSPASMS REQUIRING 10MG IA IN LEFT VERTEBRAL ARTERY AND 5MG IA VERAPAMIL IN RIGHT INTERNAL CAROTID ARTERY (ICA) AND AN ADDITIONAL 5MG. BALLOON ANGIOPLASTY WAS PERFORMED IN M1 SEGMENT DUE TO THE VASOSPASMS WHICH WERE RESOLVED ON THE SAME DAY. THE VASOSPASM WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE AND TO THE NEURON MAX. DURING THE PROCEDURE, THE FIRST SMART COIL WAS SUCCESSFULLY IMPLANTED. WHILE PLACING THE SECOND SMART COIL THROMBUS FORMATION WAS NOTED. HALF CARDIAC BOLUS DOSE OF TIROFIBAN WAS ADMINISTERED, AND LATER ANOTHER HALF CARDIAC DOSE OF TIROFIBAN WAS ADMINISTERED. PATIENT WAS GIVEN TIROF

  Patient problems: Vasoconstriction

  MAUDE report 11845804 ↗