HC300 -3T Head Coil Lower Assy HC300 Lower CoilRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857534006226), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NEUROLOGICAL PROCEDURE WITH INTRAOPERATIVE SCAN TOOK PLACE ON A (B)(6) MONTH OLD PEDIATRIC PATIENT. AFTER THE MRI SCAN WAS COMPLETED AND THE PATIENT WAS UNDRAPED, A FULL-THICKNESS BURN WAS NOTED TO THE PATIENT'S FOREHEAD. PER THE HOSPITAL AND THEIR INVESTIGATION, IT WAS DETERMINED THAT THE CAUSE OF THE BURN WAS A MEDTRONIC MR CONDITIONAL AXIEM STEALTH ARRAY THAT WAS IN PLACE ON THE PATIENT'S FOREHEAD. THERE WERE TWO FACTORS INVOLVED IN THE BURN: FIRST, THERE WAS A DISCONNECT BETWEEN THE OR AND THE MR TECHNICIAN THAT THE DEVICE WAS IN USE AND STILL ON THE PATIENT'S FOREHEAD PRIOR TO AND DURING THE SCAN; SECONDLY, THE INSTRUCTIONS FOR USE FOR THE MEDTRONIC ARRAY WAS NOT FOLLOWED FOR USE WITHIN AN MRI, THUS CREATING A FULL-THICKNESS BURN TO THE PATIENT'S FOREHEAD BY THE UNCOILED WIRE THAT CONNECTS TO THE ARRAY. AT THE TIME OF THE SCAN, IMRIS FLEX COILS WERE BEING UTILIZED HOWEVER; THERE DOES NOT APPEAR TO BE ANY RELATIONSHIP BETWEEN THE IMRIS COMPONENTS AND THE PATIENT BURN. A HOSPITAL STAFF REPORTED THE INCIDENT TO MEDTRONIC.

  Patient problems: Burn(s); Head Injury

  MAUDE report 13440837 ↗