TARGET M0035475100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540676498), received between Mar 29, 2018 and Dec 16, 2025 — classified as 1 injury, 5 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.

• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT IN A CASE OF CEREBRAL ANEURYSM EMBOLIZATION FOR SUBARACHNOID HEMORRHAGE (SAH) AT POSTERIOR CEREBRAL ARTERIES (PCA) THE SUBJECT COIL WAS PLACED AS THE THIRD COIL AND ATTEMPTED TO BE DETACHED; HOWEVER, IT COULD NOT BE DETACHED. WHEN THE COIL DELIVERY WIRE WAS REMOVED FROM THE FUNNEL OF THE POWER SUPPLY, RESISTANCE WAS ENCOUNTERED. IT WAS NOTICED THAT THE ELECTRODE PART WAS PREMATURELY DETACHED AND REMAINED INSIDE OF THE POWER SUPPLY. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT DEVICE 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 23817657 ↗
• MalfunctionJul 2, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE OPERATOR RETRACTED THE SUBJECT COIL FOR REPOSITIONING. WHEN THE SUBJECT COIL WAS REINSERTED, IT GOT CAUGHT BETWEEN THE INTRODUCER SHEATH AND THE MICROCATHETER'S HUB, AND PREMATURELY DETACHED IN THE MICROCATHETER'S SHAFT. 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 22385367 ↗
• MalfunctionMay 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS SELECTED FOR ANTERIOR COMMUNICATING ARTERY ANEURYSM PROCEDURE. HOWEVER, WHILE ADVANCING THE COIL WITHIN THE MICROCATHETER RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL AND FOUND IT TO BE STRETCHED. THUS, THE COIL ALONG WITH THE MICROCATHETER WAS WITHDRAWN AND THE COIL WAS FOUND TO BE STRETCHED AND FRACTURED. 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 21947697 ↗
• MalfunctionDec 9, 2022Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) DELIVERY WIRE WAS FOUND TO BE BROKEN/FRACTURE DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15947778 ↗
• MalfunctionMar 1, 2021Inadequate User Interface; Inadequate User Interface

  IT WAS REPORTED THAT DURING THE PROCEDURE THE MIDDLE PART OF THE SUBJECT COIL BECAME INVISIBLE UNDER FLUOROSCOPY AND PHYSICIAN STATED THAT THE PHYSICIAN MIGHT HAVE OVERTIGHTENED THE HUB WHEN THE SUBJECT COIL WAS INSERTED INTO THE MICRO CATHETER AND THE COIL GOT STRETCHED. 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 11396334 ↗
• InjuryMar 29, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE COIL (SUBJECT DEVICE) PERFORATED AND PROTRUDED OUT OF THE ANEURYSM CAUSING THE ANEURYSM TO BURST AND BLEEDING TO OCCUR. THE PATIENT WAS TREATED WITH PROTAMINE AND THE ANEURYSM WAS COILED SUCCESSFULLY AND THE BLEEDING STOPPED. THE PATIENT IS RECOVERING. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Aneurysm; Intracranial Hemorrhage; Rupture

  MAUDE report 7383134 ↗