TARGET M0035465200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252239420), received between Feb 10, 2017 and Apr 9, 2020 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS NOTED TO BE STRETCHED AND HAD PREMATURELY DETACHED DURING USE. THE SUBJECT DEVICE WAS REMOVED. THE PHYSICIAN REPLACED WITH ANOTHER OF THE SAME DEVICE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS STABLE AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9942095 ↗
• InjuryJul 3, 2018Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE FOR ANEURYSM LOCATED AT THE RIGHT POSTERIOR COMMUNICATING ARTERY, THE PHYSICIAN TRIED TO USE THE SUBJECT COIL TO COMPLETE THE PROCEDURE. THE SUBJECT COIL COULD NOT BE ADVANCED INTO THE LUMEN OF THE ANEURYSM. THE PHYSICIAN TRIED TO ADJUST THE COIL; HOWEVER, THE COIL WAS NOTED TO BE STRETCHED. WHEN THE PHYSICIAN TRIED TO REMOVE THE COIL BY DEPLOYING A STENT, THE COIL BROKE IN THE MIDDLE AND SOME PART OF THE COIL WAS LEFT INSIDE THE PATIENT¿S VESSEL. NO ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7657640 ↗
• MalfunctionFeb 10, 2017Premature Activation; Premature Activation

  DURING THE COIL EMBOLIZATION PROCEDURE, PREMATURE DETACHMENT OF THE COIL WAS REPORTED. THE SEPARATION OCCURRED AT THE DETACHMENT ZONE, WHEN THE COIL WAS BEING RETRIEVED OUT OF THE MICROCATHETER TO BE RE-SHEATHED INTO THE INTRODUCER SHEATH. THE COIL WAS COMPLETELY REMOVED FROM THE PATIENT ALONG WITH THE MICROCATHETER AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6323538 ↗