MATRIX2 M003497520SR0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540691774), received between Jan 13, 2017 and Jan 13, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 13, 2017Migration or Expulsion of Device; Premature Activation; Migration or Expulsion of Device; Premature Activation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION OF A RUPTURED ANEURYSM AT THE INTERNAL CAROTID ARTERY (ICA) SIPHON SEGMENT (SHAPE WAS NEAR ROUND AND DIAMETER APPROXIMATELY 10 MM) WITH THE SUBJECT COIL, THE COIL WAS PARTIALLY IMPLANTED ABOUT 1/3 OF THE LENGTH INTO THE ANEURYSM. DURING REPOSITIONING, THE COIL DETACHED AND DROPPED INTO THE PARENT ARTERY. AFTER FAILED ATTEMPT TO WITHDRAW THE DETACHED PIECE OF COIL BY WITHDRAWING THE DELIVERY WIRE SLOWLY AND SMOOTHLY, THE OPERATOR DECIDED TO ¿DEPLOY¿ THE COIL AND CONTINUED TO INSERT THE NEXT COIL. UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA), IT WAS OBSERVED THAT THE ARTERY LOOKED GOOD SO THE PROCEDURE WAS FINISHED. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6251248 ↗