Target M0035433100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540676092), received between Jan 11, 2019 and Jan 20, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2026Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT DEVICE GOT DETACHED INSIDE THE SHAFT OF THE MICROCATHETER. THE PHYSICIAN PULLED OUT THE SUBJECT DEVICE ALONG WITH THE MICROCATHETER AND FOUND A THROMBUS AT THE DISTAL TIP OF THE COIL. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24127237 ↗
• MalfunctionMar 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL COULD NOT BE REMOVED FROM THE MICROCATHETER. THE SUBJECT COIL WAS STUCK IN THE MICROCATHETER. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL DELIVERY WIRE WAS BROKEN FRACTURED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21648664 ↗
• MalfunctionFeb 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A COILING PROCEDURE, SUBJECT COIL GOT STRETCHED WITHIN MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL WAS FOUND TO BE BROKEN/FRACTURED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701373 ↗
• InjuryMar 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A COILING PROCEDURE IN ACOM (ANTERIOR COMMUNICATING ARTERY), THE PHYSICIAN ATTEMPTED TO DEPLOY THIRD COIL (SUBJECT DEVICE), BUT THE MICROCATHETER KEPT KICKING OUT OF THE ANEURYSM. THE PHYSICIAN MANIPULATED THE CATHETER TO TRY AND GET THE COIL (SUBJECT DEVICE) TO SIT IN THE ANEURYSM. BUT THE MICROCATHETER KICKED FULLY OUT AND WHILE TRYING TO PULL THE COIL (SUBJECT DEVICE) BACK INTO THE MICROCATHETER THE COIL (SUBJECT DEVICE) GOT HUNG UP ON THE STENT. THE PHYSICIAN HAD TO PULL WITH FORCE TO REMOVE THE COIL (SUBJECT DEVICE) AND THE COIL (SUBJECT DEVICE) SEPARATED FROM THE DELIVERY WIRE. THE PHYSICIAN THEN SUCCESSFULLY REMOVED THE COIL (SUBJECT DEVICE) WITH A SNARE, AND DID FOLLOW UP IMAGING CONFIRMING THAT THERE WAS NO HARM DONE TO THE PATIENT. 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 16550212 ↗
• MalfunctionAug 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE OF CEREBRAL ANEURYSM TREATMENT THE SUBJECT COIL DELIVERY WIRE FRACTURED IN THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265229 ↗
• InjuryAug 26, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE SUBJECT COIL WAS ADVANCING IN THE MICROCATHETER, THE SUBJECT COIL WAS OBSERVED UNDER THE FLUOROSCOPY TO BE BROKEN (AT DISTAL PART). THE MEDICAL INTERVENTION WAS PERFORMED TO REMOVE THE BROKEN PART AND INTRODUCE WITH ANOTHER COIL RESULTING 30 MINUTES SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A NEW COIL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374654 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE COIL WAS ONCE INSERTED AND RECOILING SEVERAL TIMES, BUT COIL WAS NOT PLACED IN THE RIGHT POSITION. SO, IT WAS REMOVED AND ATTEMPTED TO REINSERT BUT THERE WAS A RESISTANCE. ONCE THE COIL WAS REMOVED AND CHECKED, THERE WAS THROMBUS ADHERED. THE PRODUCT WAS EXCHANGED WITH THE SAME PRODUCT AND PROCEDURE COMPLETED WITHOUT PROBLEMS.NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THE EVENT.

  Patient problems: Thrombosis

  MAUDE report 8241413 ↗