TARGET M0035431010Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540700216), received between Mar 23, 2017 and Nov 5, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE MAIN COIL WAS BROKEN/FRACTURED DURING USE. 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 23482557 ↗
• MalfunctionOct 11, 2023Fracture; Premature Separation; Fracture; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE AND THE MAIN COIL (SUBJECT DEVICE) WAS FOUND TO BE DEPLOYED. 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 17910093 ↗
• MalfunctionSep 20, 2023Migration; Migration

  IT WAS REPORTED THAT DURING ACOMA ANEURYSM TINY ANEURYSM CASE. USED NON-STRYKER CATHETER TO DELIVER COIL AND INSERTED THE FIRST COIL (SUBJECT DEVICE). AFTER IT WAS DETACHED THE OPERATOR CHOSE ANOTHER COIL TO FILL AND DURING ADJUSTING THE SECOND COIL THE TAIL OF THE FIRST COIL (SUBJECT DEVICE) WAS PULLED TOGETHER BACK INTO MICROCATHETER AND THE COILS GOT STUCK (SUBJECT COIL MIGRATED (MOVED OUT OF POSITION ONCE PLACED)). THE OPERATOR PUSHED AND PULLED THE COIL DELIVERY WIRE BUT THE COIL COULD NOT MOVE. SO HE HAD TO WITHDRAW THE MICROCATHETER AND PULLED THE COIL OUT OF PATIENT'S BODY AND USED NEW COIL TO FINISH THE PROCEDURE. 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 17784900 ↗
• MalfunctionSep 24, 2021Premature Separation; Premature Separation

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED, LIKELY IN THE CATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530078 ↗
• MalfunctionJan 30, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING RUPTURED ANEURYSM COIL EMBOLIZATION PROCEDURE, THE SUBJECT COIL PREMATURELY DETACHED AT THE POSTERIOR COMMUNICATING ARTERY(PCOMM) INSIDE THE ANEURYSM BEFORE THE PHYSICIAN PUT THE DETACHER ON THE DELIVERY WIRE OF THE COIL. THE SUBJECT COIL REMAINED IMPLANTED INSIDE THE ANEURYSM. THE PHYSICIAN REMOVED THE DELIVERY WIRE/PROXIMAL COIL AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649363 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A STENT ASSISTED-COILING PROCEDURE OF A SMALL, UN-RUPTURED, RIGHT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC ANEURYSM IN A RELATIVELY DYSPLASTIC VESSEL. THE STENT WAS SUCCESSFULLY DEPLOYED ACROSS THE ANEURYSM NECK USING JAILED TECHNIQUE. THE PHYSICIAN ATTEMPTED TO DEPLOY A FIRST COIL 2MM X 3CM, BUT THE COIL APPEARED TO BE TOO BIG AND LONG FOR THE ANEURYSM, AS THE COIL KEPT HERNIATING DOWNWARD INTO THE PARENT VESSEL. PRIOR TO DETACHING THE COIL, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT¿S BODY. THE PHYSICIAN SWITCHED TO A 1.5MM X 2CM COIL. UNFORTUNATELY, THE SAME ISSUE HAPPENED WITH THIS COIL AS IT CONTINUED TO HERNIATE DOWN INTO THE PARENT VESSEL. PRIOR TO DETACHING THE COIL, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT¿S BODY. THE PHYSICIAN SWITCHED TO A 1MM X 1CM COIL. THIS 1MM X 1CM COIL SUCCESSFULLY DEPLOYED INTO THE ANEURYSM DOME AND WAS DETACHED. UPON INSPECTING THE COIL MASS, AS THE PHYSICIAN NOTICED THAT THERE WAS STILL OPEN SPACE IN THE MIDDLE OF THE ANEURYSM, THE PHYSICIAN DECIDED TO DEPLOY OF A SECOND 1MM X 1CM COIL (SUBJECT DEVICE) INTO THE ANEURYSM DOME. UNFORTUNATELY, THIS SECOND 1MM X 1CM COIL MECHANICALLY PUSH

  Patient problems: High Blood Pressure/ Hypertension; Intracranial Hemorrhage

  MAUDE report 9434437 ↗
• InjuryDec 6, 2019Migration; Migration

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A STENT ASSISTED-COILING PROCEDURE OF A SMALL, UNRUPTURED, RIGHT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC ANEURYSM IN A RELATIVELY DYSPLASTIC VESSEL. THE STENT WAS SUCCESSFULLY DEPLOYED ACROSS THE ANEURYSM NECK USING JAILED TECHNIQUE. THE PHYSICIAN ATTEMPTED TO DEPLOY A FIRST COIL, BUT THE COIL APPEARED TO BE TOO BIG AND LONG FOR THE ANEURYSM, AS THE COIL KEPT HERNIATING DOWNWARD INTO THE PARENT VESSEL. PRIOR TO DETACHING THE COIL, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT¿S BODY. THE PHYSICIAN SWITCHED TO A 1.5MM X 2CM COIL. UNFORTUNATELY, THE SAME ISSUE HAPPENED WITH THIS COIL AS IT CONTINUED TO HERNIATE DOWN INTO THE PARENT VESSEL. PRIOR TO DETACHING THE COIL, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT¿S BODY. THE PHYSICIAN SWITCHED TO A 1MM X 1CM COIL (SUBJECT DEVICE). THIS 1X1 COIL SUCCESSFULLY DEPLOYED INTO THE ANEURYSM DOME AND WAS DETACHED. UPON INSPECTING THE COIL MASS, AS THE PHYSICIAN NOTICED THAT THERE WAS STILL OPEN SPACE IN THE MIDDLE OF THE ANEURYSM, THE PHYSICIAN DECIDED TO DEPLOY OF A SECOND 1MM X 1CM COIL INTO THE ANEURYSM DOME. UNFORTUNATELY, THIS SECOND 1MM X 1CM COIL MECHANICALLY PUSHED THE FIRST DETA

  Patient problems: High Blood Pressure/ Hypertension; Intracranial Hemorrhage

  MAUDE report 9434271 ↗
• MalfunctionAug 30, 2019Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8952547 ↗
• MalfunctionAug 16, 2019Break; Break

  IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE FOR THE ANEURYSM AT LEFT PCOMA (POSTERIOR COMMUNICATING ARTERY), THE PUSHER WIRE OF THE COIL WAS FRACTURED INSIDE THE PATIENT. SO THE PHYSICIAN WITHDRAW THE DEVICE AND FINISHED THE PROCEDURE. NO CLINICAL CONSEQUENCE REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8903930 ↗
• MalfunctionJul 20, 2017Premature Activation; Premature Activation

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE MAIN COIL HAD DETACHED FROM THE DELIVERY WIRE. THERE WERE NO PATIENT CLINICAL CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6730365 ↗
• MalfunctionMar 23, 2017Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL SEPARATED INTO TWO PARTS. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6430513 ↗