Magellan™ MC9F80Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815671020031), received between May 25, 2016 and Jun 2, 2016 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryJun 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT, (B)(6), HAS A KNOWN RIGHT INTERNAL CAROTID ARTERY STENOSIS AS SEEN ON PRIOR DUPLEX ULTRASOUND IMAGING AND ON PRIOR CT ANGIOGRAM OF THE NECK, WITH SYMPTOMS OF DIZZINESS AND BRIGHT LIGHT VISION CHANGES, WENT THROUGH RIGHT INTERNAL CAROTID ARTERY STENT PLACEMENT, PERFORMED BY DR. (B)(6) ON (B)(6) 2016. A 9FR MAGELLAN CATHETER WAS INSERTED THROUGH L FEMORAL ARTERY AND USED TO NAVIGATE AND DELIVER TREATMENT DEVICES. ACCULINK STENT WAS POSITIONED AND DEPLOYED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED WITH INTACT NEUROLOGIC FUNCTION AND PALPABLE PEDAL PULSES. ON (B)(6) 2016, PATIENT FELT PAIN AND SWELLING ON HIS LEFT GROIN. PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND CARE. COLOR AND DUPLEX DOPPLER INTERROGATION OF THE LEFT HIGH THIGH WAS PERFORMED. THE RESULT SHOWED SUB-CENTIMETER PSEUDO-ANEURYSM IN THE LEFT GROIN. PATIENT WAS MONITORED IN THE HOSPITAL. ON (B)(6) 2016, A LIMITED COLOR DUPLEX SONOGRAPHY WAS PERFORMED AGAIN TO EVALUATE THE PSEUDO-ANEURYSM. THE RESULT SHOWED THAT THE PSEUDO-ANEURYSM WAS NO LONGER VISUALIZED, AND THERE WAS NO EVIDENCE OF RESIDUAL PSEUDO-ANEURYSM. PATIENT WAS THEN DISCHARGED WITH NO SEQUELAE.

  Patient problems: Pseudoaneurysm

  MAUDE report 5695917 ↗
• InjuryMay 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH SYMPTOMATIC RIGHT CAROTID ARTERY STENOSIS. HAD ANGIOGRAPHY ON RIGHT COMMON CAROTID ARTERY ON (B)(6) 2015. A MAGELLAN CATHETER WAS USED TO NAVIGATE FROM ACCESS SITE (LEFT FEMORAL ARTERY) TO THE RIGHT COMMON CAROTID ARTERY. ANGIOGRAPHY WAS COMPLETED SUCCESSFULLY AND FOLLOWED WITH SURGICAL PROCEDURE ON RIGHT CAROTID ENDARTERECTOMY (RIGHT CEA) THE NEXT DAY (B)(6) 2015. THE GUIDEWIRES AND DIAGNOSTIC CATHETERS USED DURING THE PROCEDURES WERE NOT MANUFACTURED OR PROVIDED BY HANSEN MEDICAL. ON (B)(6) 2015, PATIENT WAS ADMITTED TO THE HOSPITAL WITH COMPLAINT OF BILATERAL BLURRY VISION AND LEFT HAND NUMBNESS WHICH LASTED 5-10 MINUTES. MAGNETIC RESONANCE IMAGING (MRI) SHOWED NO EVIDENCE OF ACUTE CEREBRAL ISCHEMIA. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF NECK SHOWED NO THROMBUS AT RIGHT CEA OPERATIVE SITE. ON (B)(6) 2015 PATIENT WAS CONSULTED TO NEUROLOGY. NEUROLOGY CONSULTATION NOTED THE BILATERAL BLURRY VISION AND LEFT HAND NUMBNESS COMPLAINTS WERE NOT CONCLUSIVE AS A TRANSIENT ISCHEMIC ATTACK (TIA). PATIENT WAS DISCHARGED ON (B)(6) 2016.

  Patient problems: Blurred Vision; Numbness

  MAUDE report 5680189 ↗