TARGET M0036181850Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327128413), received between Sep 28, 2017 and Apr 9, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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. 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.

• MalfunctionApr 9, 2020Expulsion; Unintended Movement; Premature Separation; Expulsion; Unintended Movement; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL HAD PREMATURELY DETACHED DURING USE. IT WAS ALSO IDENTIFIED THAT THE SUBJECT COIL APPEARED PROTRUDING AND WAS SUBSEQUENTLY FIXED SUBCUTANEOUSLY BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9942072 ↗
• MalfunctionApr 1, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE COIL(SUBJECT DEVICE) WAS ADVANCED IN THE MICROCATHETER, THE COIL DETACHED PREMATURELY INSIDE THE MICRO CATHETER. THE COIL WAS RETRIEVED ALONG WITH THE MICROCATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8471750 ↗
• InjurySep 28, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING THE EMBOLIZATION PROCEDURE AGAINST TYPE II ENDOLEAK AFTER ENDOVASCULAR AORTIC REPAIR, IT WAS REPORTED THAT THE COIL GOT STUCK AND STRETCHED INSIDE THE MICROCATHETER DURING PLACEMENT IN AN INFERIOR MESENTERIC ARTERY ANEURYSM. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL TOGETHER WITH THE MICROCATHETER BUT IT DID NOT WORK. THEREFORE, A SNARE DEVICE WAS USED BUT STILL DID NOT WORK. FINALLY THE PHYSICIAN CUT OFF THE COIL, PART OF THE MAIN COIL WAS LEFT INSIDE THE PATIENT LOCATED FROM ABDOMINAL AORTIC ANEURYSM TO INFERIOR MESENTERIC ARTERY. THE PROCEDURE WAS ABORTED DUE TO 3 HOURS HAD PASSED SINCE COIL RETRIEVING STARTED AND THE INFERIOR MESENTERIC ARTERY BECAME SPASM. THE PATIENT CONDITION IS FINE BUT IS UNDER OBSERVATION AT THE MOMENT.

  Patient problems: Vasoconstriction

  MAUDE report 6901429 ↗