Target M0035434060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540676108), received between Mar 12, 2019 and Aug 27, 2019 — classified as 1 injury, 1 malfunction.

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. 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.

• MalfunctionAug 27, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DELIVERY WIRE OF THE COIL WAS BROKEN WHEN INSERTED INTO THE MICROCATHETER. NO PATIENT CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8935763 ↗
• InjuryMar 12, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS USED DURING COIL EMBOLIZATION PROCEDURE FOR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN WAS ABLE TO INTRODUCER THE COIL INTO THE PATIENT¿S ANATOMY; HOWEVER, THE COIL PREMATURELY DETACHED BEFORE REACHING THE TARGET LESION. TWO STENTS WERE IMPLANTED TO SECURE THE SUBJECT COIL IN PLACE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO KNOW CLINICAL CONSEQUENCES WAS REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8414396 ↗