TARGET M0035423060Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04546540675880), received between Jun 14, 2016 and Apr 30, 2025 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (7 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) COULD NOT BE DETACHED WHEN PLACED INTO THE ANEURYSM. ALSO, WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE IT, THE COIL GOT DETACHED WITHIN THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 60 MINUTES. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938276 ↗
• MalfunctionJan 9, 2025Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) 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 21114133 ↗
• MalfunctionJan 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE THE SUBJECT COIL COULD NOT BE DETACHED. 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 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 21072720 ↗
• MalfunctionNov 26, 2024Fracture; Fracture

  IT WAS REPORTED DURING THE PROCEDURE THERE WAS RESISTANCE ENCOUNTERED IN THE MIDDLE OF THE CATHETER SHAFT WHEN THE SUBJECT COIL WAS ADVANCED. WHEN COILING INTO THE ANEURYSM, THE PHYSICIAN THOUGHT THE SUBJECT COIL SEEMED DEFORMED AND BROKEN. THE SUBJECT COIL WAS REMOVED BY PULLING THE DELIVERY WIRE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777641 ↗
• InjurySep 3, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT (ATLAS) WAS USED TO ASSIST THE COIL EMBOLIZATION UNDER PARALLEL TECHNIQUE (ACOMA UNRUPTURED ANEURYSM SIZED 5.6X2.9MM). THE OPERATOR DEPLOYED THE STENT FIRST AT ANTERIOR CEREBRAL ARTERY (ACA) IN SAME SIDE AND THEN INSERTED THE SUBJECT COIL THROUGH THE PRE-LOCATED EMBOLIZATION MICROCATHETER FOR FRAMING. DURING INSERTING. THE TIP OF MICROCATHETER MIGRATED OUT OF ANEURYSM LUMEN, SO THE OPERATOR TRIED TO ADJUST IT TO DELIVER IT BACK. HOWEVER, DURING THIS PROCEDURE, THE SUBJECT COIL GOT STRETCHED AND FRACTURED. THE OPERATOR TRIED TO HANDLE THIS FRACTURED SUBJECT COIL, AND THIS CAUSED THE DEPLOYED STENT MIGRATED AND PART OF THE STENT PROXIMAL PART MIGRATED INTO LUMEN OF ANEURYSM. THE OPERATOR TRIED TO DELIVER A GUIDEWIRE TO REACH DISTAL OF THE STENT BUT FAILED, THEREFORE, TIROFIBAN WAS ADMINISTERED AND THROMBOLYSIS WAS TRIED FOR THE ACUTE OCCLUSION AT ANTERIOR CEREBRAL ARTERY (ACA) ON THE SAME SIDE. WHILE PERFORMING DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AGAIN, THE ANEURYSM WAS FOUND RUPTURED AND LED TO THE INTRACRANIAL HEMORRHAGE. IT WAS HARD TO DETERMINE IF THE ANEURYSM/VESSEL WAS RUPTURED BY THE STENT. THE OPERATOR FINISHED THE PROCEDURE, AND THE PATIENT WAS T

  Patient problems: Foreign Body In Patient; Intracranial Hemorrhage; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 20129936 ↗
• InjuryAug 12, 2024Migration; Migration

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE FOR A RUPTURED ANEURYSM, THE OPERATOR PLACED THE SUBJECT COIL INTO THE ANEURYSM, SUCCESSFULLY DETACHED IT AND REMOVED THE DELIVERY WIRE. NEXT, THE OPERATOR INSERTED THE SECOND COIL, HOWEVER, THE MICROCATHETER SLIPPED OUT OF THE ANEURYSM. THUS, THE SECOND COIL WAS REMOVED FROM THE MICROCATHETER. NEXT, THE OPERATOR REMOVED THE MICROCATHETER AND DURING THIS STEP THE SUBJECT COIL GOT REMOVED OUT OF THE ANEURYSM TOGETHER WITH THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. UPDATE: ADDITIONAL INFORMATION RECEIVED 01 OCT 2024 INDICATED THAT THE SUBJECT COIL COULD NOT BE RETRIEVED FROM THE PATIENT'S ANATOMY AND HAD TRAVELED TO THE PERIPHERY OF ANTERIOR CEREBRAL ARTERY (ACA) CAUSING A CEREBRAL INFARCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stroke/CVA

  MAUDE report 19964837 ↗
• MalfunctionDec 22, 2023Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT DURING ACOMA (ANTERIOR COMMUNICATING ARTERY) ANEURYSM CASE. USED THE COIL (SUBJECT DEVICE) TO FRAME. AFTER THE COIL WAS FILLED, THE OPERATOR DETACH IT AND THE INDICATOR SHOWED SUCCESSFUL DETACHMENT, AND THEN THE OPERATOR WITHDREW THE DELIVERY WIRE SLOWLY. AT THE BEGINNING THE PULLING WAS NORMAL BUT AFTER A FEW CENTIMETERS OF THE DELIVERY WIRE WAS WITHDRAWN, THE OPERATOR FOUND THE TAIL OF MAIN COIL (SUBJECT DEVICE) WAS RETRACTED BACK INTO MICROCATHETER TOGETHER WITH DELIVERY WIRE. CONTINUED TO PULL THE DELIVERY WIRE AND THE COIL (SUBJECT DEVICE) WAS NOT WITHDRAWN ANY MORE AS IT WAS SEPARATED FROM DELIVERY WIRE BY ITSELF DURING RETRACTING. SO THE OPERATOR WITHDREW THE DELIVERY WIRE COMPLETELY. THEN THE OPERATOR WITHDREW THE MICROCATHETER WHICH MADE THE COIL (SUBJECT DEVICE) MIGRATED FROM MICROCATHETER TO VESSEL. THEN THE OPERATOR USED TWO MICROCATHETERS TO PUSH THE MIGRATED COIL INTO ANEURYSM AND CONTINUED TO FILL COILS AND USED STENT TO SUPPORT. 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 18387435 ↗
• MalfunctionOct 11, 2022Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE WHILE RE-POSITIONING THE SUBJECT COIL AND RE-INSERTING IT INTO THE CATHETER, THE DEVICE WAS DETACHED FROM THE DELIVERY WIRE AND STUCK IN THE CATHETER. THE PHYSICIAN USED A GUIDEWIRE TO REMOVE THE DETACHED COIL FROM THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580908 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE IN A PATIENT WITH INTERNAL CAROTID PARACLINOID ANEURYSM, THE SUBJECT COIL GOT STRETCHED WHILE RE-POSITIONING IT WITHIN THE ANEURYSM. THE STRETCHED SUBJECT COIL WAS REMOVED FROM THE PATIENT VASCULATURE USING A GOOSENECK SNARE. 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 15499362 ↗
• MalfunctionMar 8, 2021Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) WAS BROKEN DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11439433 ↗
• MalfunctionFeb 19, 2021Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE MAIN COIL HAD PREMATURELY DETACHED DURING USE. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355838 ↗
• MalfunctionJan 6, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING THE PROCEDURE OF COIL EMBOLIZATION FOR SUBARACHNOID HEMORRHAGE (SAH), SUBJECT COIL WAS ADVANCED INTO MICROCATHETER UP TO SECOND INDICATION MARKER. THE PHYSICIAN THEN FOUND THAT THE DETACHMENT POINT HAD COME OUT OF THE TIP OF THE MICROCATHETER. THE PHYSICIAN'S OPINION WAS THAT THE MARKER POSITION OR THE LENGTH BETWEEN TIP OF DELIVERY WIRE AND MARKER WAS INCORRECT. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11128725 ↗
• InjuryDec 5, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE OF MCA (MIDDLE CEREBRAL ARTERY) CHILD ANEURYSM COIL EMBOLIZATION UNDER DSA (DIGITAL SUBTRACTION ANGIOGRAPHY), ACCESS WAS OBTAINED BY PUNCTURING RIGHT FEMORAL ARTERY WITH SELDINGER TECHNIQUE. USED GUIDEWIRE AND MICROCATHETER TO REACH TO THE CHILD ANEURYSM AT MCA (MIDDLE CEREBRAL ARTERY). STARTED COIL EMBOLIZATION. WHEN THIS COIL (SUBJECT DEVICE) WAS USED, BIG RESISTANCE WAS ENCOUNTERED WHILE ADVANCEMENT OF THE COIL INTO THE MICROCATHETER TO GO INTO THE ANEURYSM. THE OPERATOR TRIED SEVERAL TIMES BUT STILL COULDN'T PUSH IT, SO TRIED TO WITHDRAW THE COIL WITH MICROCATHETER AND FOUND THAT MID SECTION OF THE COIL WAS FRACTURED IN THE MICROCATHETER LUMEN. SO SNARE IS USED TO REMOVE ALL PART OF THE FRACTURED COIL FROM THE PATIENT ANATOMY. IT WAS ALSO REPORTED THAT THERE WAS 1 HOUR OF SURGICAL DELAY NOTED, AND NO ADVERSE CONSEQUENCES REPORTED DUE TO THE SURGICAL DELAY. 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 10954447 ↗
• MalfunctionOct 6, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS USED DURING EMERGENCY EMBOLISM AFTER PANCREATECTOMY. RESISTANCE WAS REPORTED WHEN ADVANCING THE SUBJECT COIL THROUGH THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO PLACE THE SUBJECT COIL IN THE TARGET SITE AND WHEN TRIED TO DETACH THE COIL USING THE DETACHMENT SYSTEM AFTER CONFIRMING THE POSITION OF THE MARKER, LONG BEEP CONTINUED, AND THE COIL COULD NOT BE DETACHED. THE PHYSICIAN TRIED TO DETACH THE COIL 5 TO 6 TIMES; HOWEVER; SIMILAR EVENT OCCURRED. THE PHYSICIAN PULLED THE COIL SLOWLY BUT IT DETACHED INSIDE THE MICROCATHETER. THE DELIVERY WIRE OF THE COIL WAS REMOVED, AND THE SUBJECT COIL WAS PUSHED INTO THE VESSEL USING A GUIDEWIRE. OTHER PRODUCTS WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10633116 ↗
• MalfunctionApr 30, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE THE SUBJECT COIL PREMATURELY DETACHED IN THE CATHETER. THE COIL WAS REMOVED FROM THE PATIENT WITHOUT ANY HEALTH HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO IMPACT TO THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10015209 ↗
• MalfunctionJul 31, 2019Break; Break

  IT WAS REPORTED THAT THE DELIVERY WIRE BROKE DURING PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8849064 ↗
• InjuryMar 4, 2019Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE BY COILING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THE COIL (SUBJECT DEVICE) DID NOT DETACH. AFTER MULTIPLE ATTEMPTS TO DETACH THE COIL, THE PHYSICIAN DECIDED TO PULL BACK THE COIL IN THE MIDDLE OF MICROCATHETER AND PART OF THE COIL REMAINED IN THE ANEURYSM. LATER ON, THE PROXIMAL PART OF THE COIL MIGRATED FROM THE CATHETER AND OCCLUDED THE ANTERIOR CEREBRAL ARTERY (ACA). THERE WERE NO MEDICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Occlusion

  MAUDE report 8388721 ↗
• MalfunctionFeb 27, 2019Premature Separation; Premature Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8375709 ↗
• MalfunctionNov 2, 2018Break; Break

  IT WAS REPORTED THAT THE DURING THE COIL EMBOLIZATION PROCEDURE, THE SUBJECT COIL WAS NOT PASSING THROUGH THE DISTAL END OF MICROCATHETER. WHILE TRYING TO REMOVE THE COIL, IT GOT BROKE INSIDE THE MICROCATHETER. THE COIL WAS SUCCESSFULLY REMOVED ALONG WITH THE MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8035238 ↗
• MalfunctionAug 17, 2018Migration; Migration

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM LOCATED ON THE ACOM (ANTERIOR COMMUNICATING ARTERY) WITH SUB ARACHNOIDID BLEEDING, WHEN PLACING THE 4TH COIL, THE 4TH COIL CAME OUT OF THE MICROCATHETER STIFF AND STRETCHED. ATTEMPT WAS MADE TO PLACE THE 4TH COIL BUT IT BROKE OFF WHEN TRYING TO REMOVE AGAIN. EVENTUALLY, THE 4TH COIL WAS RETRIEVED WITH THE MICROCATHETER, REMOVING AT THE SAME TIME THE 3RD IMPLANTED COIL (SUBJECT DEVICE) THAT WAS LOCKED TO THE 4TH COIL. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7792367 ↗
• MalfunctionNov 28, 2017Break; Break

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE DELIVERY WIRE WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7063776 ↗
• MalfunctionNov 2, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE MAIN COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER SHAFT INSIDE THE PATIENT. THE COIL AND THE MICROCATHETER WERE REMOVED FROM THE PATIENT AS ONE UNIT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6074556 ↗
• InjurySep 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SUCCESSFUL MECHANICAL THROMBECTOMY OF THE LEFT M2 MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION WITH THE SUBJECT RETRIEVAL DEVICE. ONE PASS WAS MADE WITH THE RETRIEVAL DEVICE AND ASPIRATION WAS USED TWO TIMES. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 3 AFTER TREATMENT. HOWEVER, AFTER THE INDEX PROCEDURE, THE PATIENT SUFFERED A SYMPTOMATIC INTRACRANIAL HEMORRHAGE. NO TREATMENT WAS REQUIRED AND THE OUTCOME WAS REPORTED AS RESOLVED. FOURTEEN DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED TO GENERAL HOSPITAL FOR SHORT TERMS. THE EVENT WERE REPORTED TO BE RELATED TO THE PROCEDURE AND UNKNOWN IF RELATED TO THE DEVICE.

  Patient problems: Hemorrhage, Cerebral

  MAUDE report 5967432 ↗
• MalfunctionSep 1, 2016Premature Activation; Premature Activation

  DURING PROCEDURE THE PHYSICIAN WAS TRYING TO DETACH A COIL, PRESSED INZONE, AND RECEIVED A LONG BEEP, THEN PRESSED THE INZONE AGAIN AND AFTER RECEIVING THE 3 BEEPS PRESUMED THAT THE COIL DETACHED. PHYSICIAN PULLED BACK THE MICROCATHETER TO CHECK UNDER THE FLUOROSCOPY IF THE COIL DETACHED, BUT THE MICROCATHETER POPPED OUT OF THE ANEURYSM, COIL WAS PULLED INTO THE MICROCATHETER AND PREMATURELY DETACHED. THE COIL AND DELIVERY WIRE WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND THERE WAS NO CLINICAL CONSEQUENCE NOTED TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5923103 ↗
• InjuryJun 28, 2016Migration or Expulsion of Device; Premature Activation; Migration or Expulsion of Device; Premature Activation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING (ACOM) ARTERY, THE SECOND COIL DETACHED UNEXPECTEDLY WHILE BEING REPOSITIONED. THE PHYSICIAN DID NOT REMOVE THE COIL BECAUSE A RETRIEVAL DEVICE WAS NOT AVAILABLE; HOWEVER, AN UN-SPECIFIED TREATMENT WAS ADMINISTERED AND THE PROCEDURE WAS TERMINATED. THE PHYSICIAN INDICATED THAT STEROID WILL BE ADMINISTERED TO THE PATIENT IF THERE IS HEADACHE COMPLAINTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5756466 ↗