TARGET M0035477150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540676566), received between Jul 26, 2016 and Dec 22, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE REMOVAL OF THE SUBJECT COIL FROM THE HIVE (DISPENSER HOOP), IT WAS NOTICED THAT THE DISTAL REGION OF THE SUBJECT COIL WAS BROKEN. YET, THE SUBJECT COIL WAS PREPARED AND POSITIONED INSIDE THE ANEURYSM, WHEN ATTEMPTED TO DETACH IT THE SUBJECT COIL WAS UNABLE TO GET DETACHED. THERE WAS A SURGICAL DELAY OF 5-10 MIN DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874178 ↗
• InjuryDec 6, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE SUBJECT COIL THROUGH THE MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON 14 NOV 2024, THAT A RETRIEVER WAS REQUIRED TO REMOVE THE COIL FROM THE MICROCATHETER AS A MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 26 NOV 2024 THAT THE COIL HAD PREMATURELY DETACHED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861716 ↗
• InjuryOct 17, 2024Expulsion; Premature Separation; Expulsion; Premature Separation

  IT WAS REPORTED THAT DURING AN INTERNAL CAROTID ARTERY (ICA) WIDE NECK ANEURYSM CASE, DURING COILING SUBJECT COIL GOT PREMATURELY DETACHED HALFWAY IN THE ANEURYSM AND HALF IN THE VESSEL. TAIL OF THE SUBJECT COIL WAS PROTRUDING IN THE ICA; THEREFORE, A STENT WAS PLACED TO SECURE THE SUBJECT COIL TO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473169 ↗
• InjuryAug 26, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE COIL PREMATURELY DETACHED INSIDE THE PATIENT. THEREFORE, THE PHYSICIAN USED THE SNARE TO REMOVE THE DETACHED COIL. NO FURTHER INFORMATION IS AVAILABLE FOR NOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8933446 ↗
• MalfunctionJul 26, 2016Premature Activation; Premature Activation

  DURING AN ATTEMPT TO COIL AN ARTERY, THE PHYSICIAN ENCOUNTERED RESISTANCE AT THE TIP OF THE COMPETITOR MICROCATHETER. THE PHYSICIAN PULLED BACK THE MICROCATHETER WHILE PUSHING FORWARD THE COIL; HOWEVER, RESISTANCE WAS STILL MET. IT WAS REPORTED THAT WHEN DELIVERY WIRE WAS RETRACTED, THE COIL REMAINED IN THE MICROCATHETER. SINCE THE COMPETITOR MICROCATHETER WAS BEING USED TO INFUSE MEDICATION, THE MICROCATHETER ALONG WITH THE COIL WERE REMOVED AND PLACED IN A RADIATION DISPOSAL BAG. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5822236 ↗