TARGET M0035425100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540675958), received between Oct 5, 2016 and Feb 6, 2025 — classified as 2 injuries, 4 malfunctions.

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

• MalfunctionFeb 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN ADVANCING THE SUBJECT COIL THROUGH THE MICROCATHETER, THE SUBJECT COIL GOT STUCK IN THE MIDDLE OF THE MICROCATHETER SHAFT AND WHEN AN ATTEMPT WAS MADE TO RETRIEVE IT, THE SUBJECT COIL BECOME STUCK IN THE MICROCATHETER SHAFT AND THE DELIVERY WIRE BROKE INSIDE THE MICROCATHETER SHAFT. THE ENTIRE MICROCATHETER WAS RETRIEVED. 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 21327693 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, WHEN THE SUBJECT COIL WAS PLACED. THE SUBJECT COIL BECAME STRETCHED AFTER REPOSITIONED SEVERAL TIMES AND THE SNARE WAS USED TO RETRIEVE IT. 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 17331462 ↗
• MalfunctionNov 30, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE, THE SUBJECT COIL FELT RESISTANCE ADVANCING THE INTRODUCER SHEATH. WHEN THE OPERATOR ADVANCED THE SUBJECT COIL THROUGH THE MICROCATHETER, THE SUBJECT COIL GOT STUCK IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE OPERATOR TRIED TO PULL BACK THE SUBJECT COIL, WHILE DOING SO THE SUBJECT COIL DETACHED PREMATURELY IN THE MICROCATHETER. THE SUBJECT COIL AND THE MICROCATHETER WERE 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 15890782 ↗
• MalfunctionNov 28, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ICPC (INTERNAL CAROTID - POSTERIOR COMMUNICATING ARTERY) DOUBLE CATHETER ANEURYSM EMBOLIZATION PROCEDURE, WHILE COILING THE ANEURYSM WHEN THIS COIL (SUBJECT DEVICE) WAS USED THERE WAS STRONG RESISTANCE AND IT FELT AS IF THE COIL WAS GOING TO STRETCHED. SO, THE COIL WAS ATTEMPTED TO REMOVE ALONG WITH THE MC, BUT IT PREMATURELY DETACHED (DETACHED UNINTENTIONALLY WITHOUT USING IN-ZONE), BUT OPERATOR WAS ABLE TO PLACE. THE PREMATURELY DETACHED COIL INSIDE THE ANEURYSM. 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 10915331 ↗
• InjuryMar 16, 2017Premature Activation; Premature Activation

  THE PHYSICIAN EXPERIENCED FRICTION WHILE TRYING TO REPOSITIONED THE COIL. IT WAS REPORTED THAT THE COIL WAS REPOSITIONED APPROXIMATELY 3 TO 4 TIMES WHEN IT DETACHED. THE PHYSICIAN PROCEEDED TO CUT THE HUB OF THE MICROCATHETER IN ATTEMPT TO REMOVE THE COIL; HOWEVER, THE COIL BECAME JAMMED IN THE MICROCATHETER; THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER ALONG WITH THE COIL. THERE WAS A SURGICAL DELAY, AND THE PATIENT'S BLOOD PRESSURE DROPPED SEVERAL TIMES AND THE PATIENT LOST ONE LITER OF BLOOD. IT WAS REPORTED THAT THERE WAS NO RESIDUAL EFFECT ON THE PATIENT DUE TO THIS EVENT.

  Patient problems: Blood Loss; Low Blood Pressure/ Hypotension

  MAUDE report 6412024 ↗
• MalfunctionOct 5, 2016Premature Activation; Premature Activation

  THE PHYSICIAN WAS UNABLE TO DETACHED THE COIL AFTER SEVERAL DETACHMENT ATTEMPTS; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. IT WAS REPORTED THAT AS THE COIL WAS BEING REMOVED, IT PREMATURELY DETACHED, RESULTING IN PART OF THE COIL PROTRUDING INTO THE PARENT VESSEL. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6001613 ↗