MATRIX2 M003497320SR0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540691699), received between Mar 29, 2018 and Oct 3, 2018 — classified as 3 injuries.

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

• InjuryOct 3, 2018No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED RESISTANCE WAS FELT, THE COIL STRETCHED AND WAS REMOVED FROM THE PATIENT WITH A SNARE DEVICE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7932535 ↗
• InjuryJul 3, 2018Break; Break

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM, WHEN HALF OF THE COIL (SUBJECT DEVICE) WAS ALREADY INSIDE THE ANEURYSM SAC, THE COIL ELONGATED/STRETCHED AND THE PHYSICIAN WAS NOT ABLE TO CONTROL THE COIL. THE COIL BROKE INTO 2 PARTS. THE PART OF THE COIL INSIDE THE ANEURYSM WAS SUCCESSFULLY REMOVED USING A REMOVER DEVICE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7660683 ↗
• InjuryMar 29, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED INSIDE THE PATIENT DURING THE PROCEDURE. THE COIL WAS RETRIEVED ALONG WITH THE MICROCATHETER USING A GOOSE NECK SNARE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT COIL. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7382255 ↗