TARGET M0035421520Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04546540697981), received between Jun 29, 2016 and Mar 19, 2026 — classified as 11 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (9 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE THERE WAS RESISTANCE WHEN THE SUBJECT COIL WAS ADVANCED THROUGH THE CATHETER AND THE SUBJECT COIL GOT PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE COIL WAS REPLACED A NEW ONE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646275 ↗
• MalfunctionFeb 26, 2026Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL DID NOT DETACH WITH THE RELEASE SYSTEM. AFTER THEN, WHILE REMOVING THE SUBJECT COIL HOLDER FROM THE ANEURYSM, THE SUBJECT COIL CAME OUT WITH ITS PUSHER AND DETACHED IN THE MICROCATHETER. 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 24451113 ↗
• MalfunctionJun 10, 2025Fracture; Fracture

  IT WAS REPORTED DURING THE PROCEDURE THE PROXIMAL PART OF THE SUBJECT COIL FRACTURED. THE DEVICE WAS REMOVED AND REPLACED WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179528 ↗
• MalfunctionJun 4, 2025Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146328 ↗
• MalfunctionJan 4, 2024

  PROVIDER MET RESISTANCE AND WAS NOT ABLE TO ADVANCE AND DEPLOY THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18442761 ↗
• MalfunctionNov 28, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PCOMA (POSTERIOR COMMUNICATING ARTERY) ANEURYSM EMBOLIZATION CASE, AFTER THE COIL (SUBJECT DEVICE) WAS DELIVERED TO GO INTO ANEURYSM, THE OPERATOR PULLED IT BACK A LITTLE FOR ADJUSTMENT AND WHEN THE IT REACHED TIP OF MICROCATHETER IT DETACHED UNEXPECTEDLY. THE OPERATOR 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 15874219 ↗
• MalfunctionJun 13, 2022Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL (SUBJECT DEVICE) WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14673697 ↗
• MalfunctionMay 23, 2022Fracture; Premature Separation; Fracture; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE FOR A RUPTURED CEREBRAL ARTERY ANEURYSM, AFTER SEVERAL COILS WERE PLACED IN THE ANEURYSM, THERE WAS RESISTANCE WHEN THE SUBJECT COIL WAS ADVANCED THROUGH THE MICROCATHETER AND WHEN RETRIEVED THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE TIP OF THE MICROCATHETER. THE DETACHED SUBJECT COIL WAS REMOVED FROM THE PATIENT VASCULATURE ALONG WITH THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER TREATMENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470245 ↗
• MalfunctionMar 14, 2022Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT, A ANEURYSM EMBOLIZATION PROCEDURE WAS PERFORMED IN A PATIENT. DURING THE PROCEDURE THE OPERATOR INSERTED SUBJECT COIL TO GO INTO THE ANEURYSM, THE OPERATOR THEN INSERTED A 1.5X3 COIL. HOWEVER WHEN DELIVERED 1.5X3 COIL TO DISTAL OF THE MICROCATHETER RESISTANCE WAS ENCOUNTERED AND ONLY PART OF THE 1.5X3 COIL WAS INSERTED INTO ANEURYSM AND REST OF THE 1.5X3 COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER. AFTER SEVERAL TRIES THE OPERATOR DECIDED TO WITHDRAW THE 1.5X3 COIL. AT THIS POINT IN THE PROCEDURE, WHEN RETRIEVING THE 1.5X3 COIL, THE 1.5X3 COIL TANGLED WITH THE PREVIOUSLY INSERTED SUBJECT COIL. THEREFORE THE SUBJECT COIL MIGRATED FROM ANEURYSM INTO THE LUMEN OF THE MICROCATHETER. SO THE OPERATOR WITHDREW THE MICROCATHETER TOGETHER WITH THE TWO COILS. THE SUBJECT COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758333 ↗
• MalfunctionFeb 3, 2022Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL DELIVERY WIRE BROKEN/FRACTURED 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 13442067 ↗
• MalfunctionDec 2, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL DELIVERY WIRE BROKEN/ FRACTURED 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 12920523 ↗
• MalfunctionMar 30, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SUBJECT COIL WAS ADVANCING WITHIN THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. WHEN THE SUBJECT COIL WAS REMOVED IT WAS FOUND TO HAVE BROKEN IN THE MIDDLE SECTION. THE PHYSICIAN TOOK THE MICRO CATHETER OUTSIDE THE BODY AND FLUSHED IT TO COMPLETELY REMOVE THE SUBJECT COIL FRAGMENTS. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587212 ↗
• InjuryJun 10, 2020Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE COIL (SUBJECT DEVICE). THE SUBJECT COIL WAS RETRIEVED BUT DURING REPOSITIONING, THE SUBJECT COIL INADVERTENTLY DETACHED WITH A COIL LOOP PROLAPSING INTO THE ANTERIOR COMMUNICATING ARTERY COMPLEX. A REVASCULARIZATION DEVICE WAS USED TO RETRIEVE THE PROLAPSED SUBJECT COIL. THE SUBJECT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10141128 ↗
• MalfunctionDec 30, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THE COIL (SUBJECT DEVICE) WOULD NOT DETACH. WHEN IT WAS ATTEMPTED TO PULL BACK INTO CATHETER, IT DETACHED. THE COIL WAS REMOVED WITH THE MICROCATHETER AS ONE UNIT. THE COIL AND CATHETER WERE REPLACED TO COMPLETE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530697 ↗
• 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, 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 (SUBJECT DEVICE). 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 INTO THE ANEURYSM DOME. UNFORTUNATELY, THIS SECOND 1MM X 1CM COIL MECHANICALLY PUSHED THE FIR

  Patient problems: High Blood Pressure/ Hypertension; Intracranial Hemorrhage

  MAUDE report 9434519 ↗
• MalfunctionNov 6, 2019Premature Separation; Premature Separation

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE COIL WAS PREMATURELY DETACHED IN THE RHV (ROTATING HEMOSTATIC VALVE) CONNECTING WITH THE MICROCATHETER HUB. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9288737 ↗
• MalfunctionOct 29, 2019Premature Separation; Premature Separation

  DURING THE ANALYSIS FOR THE RETURNED DEVICE, IT WAS REVEALED THAT THE MAIN COIL WAS PREMATURELY DETACHED INSIDE THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9254024 ↗
• InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY IN PLACING THE COIL (SUBJECT DEVICE) AND A STROKE OCCURRED FOLLOWED BY A THROMBUS FORMATION INSIDE THE PATIENT VESSEL. THE PHYSICIAN USED A MICROCATHETER TO REMOVE THE THROMBUS AND ENDED THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Stroke/CVA; Thrombus

  MAUDE report 8286293 ↗
• MalfunctionOct 31, 2018Break; Break

  ANALYSIS OF THE DEVICE REVEALED THAT THE SUBJECT COIL DELIVERY WIRE WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026562 ↗
• InjuryOct 15, 2018Migration; Migration

  DURING COIL EMBOLIZATION OF ANEURYSM LOCATED AT THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION, THE COIL WAS REPOSITIONED 2-3 TIMES. THE COIL DETACHED AND CONFIRMED THROUGH FLUOROSCOPY. IT WAS OBSERVED THAT 0.5CM OF THE COIL WAS HANGING OUT OF THE NECK OF THE ANEURYSM AND WAS FOUND TO BE STRETCHED. A STENT WAS DEPLOYED IN ORDER TO PREVENT THE COIL HANGING IN THE VESSEL. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7967620 ↗
• MalfunctionSep 6, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO PULL THE COIL BACK TO REPOSITION IT, THE COIL DETACHED PREMATURELY FROM THE COIL DELIVERY WIRE. THE COIL WAS RETRIEVED ALONG WITH THE MICROCATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7853336 ↗
• InjuryJan 10, 2018Migration or Expulsion of Device; Premature Activation; Migration or Expulsion of Device; Premature Activation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE COIL PREMATURELY DETACHED AND MIGRATED TO MIDDLE CEREBRAL ARTERY(MCA). THE COIL WAS RETRIEVED WITH GOOSENECK SNARE, BUT SOME CLOT WAS FORMED IN ANTERIOR CEREBRAL ARTERY(ACA )AND MIDDLE CEREBRAL ARTERY(MCA )AREA DURING COIL RETRIEVAL. THE CLOT WAS RETRIEVED BY THROMBECTOMY AND THE COIL EMBOLIZATION WAS COMPLETED AFTER THE THROMBECTOMY.

  Patient problems: Thrombosis

  MAUDE report 7181155 ↗
• MalfunctionOct 27, 2017Break; Break

  THE STICKER WAS FOUND ON A USAGE BOOK WITH A NOTE "SNAPPED". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6985056 ↗
• InjurySep 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION. POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A MRS OF 0. IT WAS REPORTED THAT 9 MONTHS POST PROCEDURE, THE PATIENT EXPERIENCED BILATERAL WEAKNESS. THE BILATERAL WEAKNESS WAS ONGOING AND A MRI PROCEDURE WAS PERFORMED SHOWING STABLE FINDINGS CONSISTENT WITH CHRONIC SMALL VESSEL ISCHEMIC WHITE MATTER CHANGE. NO INFARCTION WAS IDENTIFIED. ACCORDING TO THE PHYSICIAN, THE BILATERAL WEAKNESS WAS UNRELATED TO THE PROCEDURE AND STENTS. HOWEVER IT IS UNKNOWN IF THE BILATERAL WEAKNESS WAS RELATED TO THE IMPLANTED COILS (SUBJECT DEVICES). THE PATIENT WAS ASSESSED HAVING A MRS OF 0 AT 2, 6 AND 12 MONTHS AND A NIHHS OF 0 AT 12 MONTHS POST THE INDEX PROCEDURE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 6865514 ↗
• InjurySep 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE BASILAR ARTERY APEX. POST-PROCEDURE, THE PATIENT WAS ASSESSED HAVING A MODIFIED RANKING SCALE (MRS) OF 0. IT WAS REPORTED THAT A DAY POST-PROCEDURE, THE PATIENT EXPERIENCED HEADACHE. THE HEADACHE WAS RESOLVED WITHIN ONE MONTH POST-PROCEDURE. THE PATIENT¿S HEADACHE WAS TREATED WITH MEDROL DOSE PACK, IV FLUIDS (1000 ML), IV HYDROMORPHINE (1 MG), IV DEXAMETHASONE (6MG). ACCORDING TO THE PHYSICIAN, THE HEADACHE WAS POSSIBLY RELATED TO THE PROCEDURE AND STENT. HOWEVER, IT IS UNKNOWN IF THE HEADACHE WAS RELATED TO THE IMPLANTED COILS (SUBJECT DEVICE) AND ACCESS DEVICES. DURING THE 2 MONTHS FOLLOW-UP, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. AT THE 6 MONTHS FOLLOW UP POST THE INDEX PROCEDURE, THE PATIENT WAS ASSESSED HAVING A NIHHS AND MRS OF 0. IN ADDITION, DURING THE 6 MONTHS VISIT, THE PATIENT WAS STILL TAKING EXCEDRINE FOR MIGRAINE HISTORY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6863993 ↗