MICRUSFRAME MFR140225Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704077947), received between Apr 19, 2019 and Apr 19, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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 16, 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.

• MalfunctionApr 19, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE INNER, STERILE PACKAGING OF THE 2MM X 2.5CM MICRUSFRAME 14 COIL (MFR140225 / LOT# UNKNOWN) WAS FOUND DEFECTIVE WHEN THE OUTER PACKAGING WAS REMOVED. THE INNER PACKAGING WAS DAMAGED / OPENED AT THE LOWER PART. IT WAS REPORTED THAT THE OUTER PRODUCT BOX WAS DAMAGED; TORN WITH JAGGED EDGES. IT WAS CONFIRMED THAT THE COMPROMISED SEAL WAS NOT A RESULT OF THE PRODUCT BEING OPENED IN ANTICIPATION OF USE AND THEN WAS RE-SHELVED. THE COMPROMISED INNER PACKAGING ISSUE WAS NOTICED AFTER THE PRODUCT WAS RECEIVED AND HAD BEEN STORED IN THE LAB BUT PRIOR TO THE DEVICE USE. THE DEVICE WAS STORED IN A CABINET THAT IS USED FOR CONSIGNMENT GOODS; THE DEVICE WAS NOT FOLDED FOR STORAGE. THE DEVICE WAS NOT USED FOR THE PROCEDURE; ANOTHER DEVICE WAS USED. THE REPORTED EVENT DID NOT RESULT IN ANY PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533713 ↗
• MalfunctionApr 19, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE INNER, STERILE PACKAGING OF THE 2MM X 2.5CM MICRUSFRAME 14 COIL (MFR140225 / LOT# UNKNOWN) WAS FOUND DEFECTIVE WHEN THE OUTER PACKAGING WAS REMOVED. THE INNER PACKAGING WAS DAMAGED / OPENED AT THE LOWER PART. THE DEVICE WAS NOT USED FOR THE PROCEDURE; ANOTHER DEVICE WAS USED. THE REPORTED EVENT DID NOT RESULT IN ANY PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533427 ↗