TARGET M0035424060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540675910), received between Jul 20, 2017 and Nov 4, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, WHEN THE COIL WAS PLACED IN THE ANEURSYM DURING DETACHMENT A SMALL PORTION OF THE TAIL END OF THE COIL DELIVERY WIRE BROKE OFF IN THE DETACHMENT DEVICE AND THE COIL COULD NOT BE DETACHED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468485 ↗
• MalfunctionJul 24, 2025Fracture; Premature Separation; Fracture; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL HAD TO BE REPOSITIONED FOR PLACEMENT. WHEN THE COIL WAS RETRIEVED BACK INTO THE CATHETER, IT DETACHED AND WAS FRACTURED INTO TWO PARTS. ONE FRAGMENT WAS REMOVED FROM THE CATHETER AND ONE FRAGMENT REMAINED IN THE CATHETER. THE DEVICE WAS REPLACED, AND 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 WAS EXAMINED, AND IT WAS DISCOVERED THAT THE REPORTED EVENT OF THE SUBJECT MAIN COIL WAS DETACHED AT THE DISTAL END OF MICROCATHETER SHAFT AND WAS BROKEN INTO TWO PARTS DURING USE WAS NOT CONFIRMED. THE SUBJECT COIL DELIVERY WIRE WAS FOUND TO BE KINKED, THE MAIN COIL WAS FOUND TO BE STRETCHED, AND THE SUTURE OF SUBJECT MAIN COIL WAS FOUND TO BE DAMAGED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586491 ↗
• MalfunctionMar 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN INSERTING THE SUBJECT COIL INTO THE RHV (ROTATING HEMOSTASIS VALVE) OF THE MICROCATHETER DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, THE FLUORO-SAVER MARKERS WERE VISIBLE ON THE COIL DELIVERY WIRE. HOWEVER, THE SUBJECT COIL HAD ALREADY REACHED THE ANEURYSM WHEN THE FLUOROSCOPY WAS TURNED TO VISUALIZE THE COIL POSITION. THE SUBJECT COIL WAS IMPLANTED WITHOUT ANY ISSUES, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590255 ↗
• InjurySep 28, 2022Expulsion; Premature Separation; Expulsion; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) WAS ACCIDENTALLY DEPLOYED PARTIALLY OUTSIDE OF AN ACOM ( ANTERIOR COMMUNICATING ARTERY) ANEURYSM AND WAS SUSPENDED IN THE PARENT ACA (ANTERIOR CEREBRAL ARTERY) VESSEL. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE COIL USING A RETRIEVER AND CATHETER (UNDER ASPIRATION). THE PATIENT DEVELOPED VASOSPASM IN THE RIGHT MCA (MIDDLE CEREBRAL ARTERY) WHICH CLEARED AFTER 10 MINUTES OF THE PHYSICIAN ADMINISTERING VERAPAMIL. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE BY PLACING FIVE COILS IN THE ANEURYSM AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Vasoconstriction

  MAUDE report 15500202 ↗
• MalfunctionMar 17, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE DELIVERY WIRE WAS BROKEN DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11509810 ↗
• InjuryJul 20, 2017Premature Activation; Premature Activation

  DURING A COIL EMBOLIZATION PROCEDURE, DETACHMENT OF THE COIL WAS PERFORMED; HOWEVER, THE COIL DID NOT DETACH. IT WAS REPORTED THAT DURING WITHDRAWAL OF THE COIL, IT DETACHED, AND A SNARE DEVICE WAS USED TO REMOVE THE COIL. THE PROCEDURE WAS CONTINUED WITH ANOTHER COIL WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6730367 ↗