TARGET M0035475200Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04546540676511), received between May 18, 2016 and Aug 26, 2025 — classified as 6 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER ABOUT THREE LOOPS WERE COILED IN THE ANEURYSM, WHEN THE SUBJECT COIL DELIVERY WIRE WAS PULLED BACK FOR ENGAGING WITH THE VESSEL, THE COIL DID NOT COME ALONG. WHEN THE SUBJECT COIL WAS REMOVED WITH THE ENTIRE MICROCATHETER FROM THE BODY, THE COIL WAS FOUND TO BE PREMATURELY DETACHED. THE FIRST SIX LOOPS WERE IN THE ANEURYSM, AND THE REST OF SUBJECT COIL AND THE DELIVERY WIRE WERE REMOVED FROM THE MICROCATHETER SHAFT AFTER THEY WERE REMOVED ALONG WITH THE MICROCATHETER FROM THE BODY. THE COIL 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 22895984 ↗
• MalfunctionOct 17, 2024Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT MAIN COIL AND COIL DELIVERY WIRE OF SUBJECT DEVICE WAS 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 20472814 ↗
• MalfunctionAug 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE MIDDLE CEREBRAL ARTERY (MCA) PROCEDURE THE SUBJECT COIL BROKE INSIDE THE MICROCATHETER. THE SUBJECT COIL AND 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 19919919 ↗
• MalfunctionOct 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE, THE OPERATOR POSITIONED THE MICROCATHETER IN THE ANEURYSM, THERE AFTER THE OPERATOR TRANSFERRED THE SUBJECT COIL INTO THE MICROCATHETER AND DEPLOYED THE SUBJECT COIL INSIDE THE ANEURYSM. SUDDENLY THE OPERATOR FELT RESISTANCE WHEN CONTINUING TO ADVANCE IT. THE OPERATOR DECIDED TO REMOVE THE SUBJECT COIL, WHEN DOING SO THE OPERATOR FELT THAT THE SUBJECT COIL WAS NOT COMING OUT COMPLETELY. THE OPERATOR SAW THAT THE SUBJECT COIL HAD BEEN CUT (WITHOUT HAVING RELEASED IT) IN A PORTION, LEAVING A PIECE OF SUBJECT COIL INSIDE THE MICROCATHETER. IT WAS REPORTED THAT 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 17954126 ↗
• MalfunctionSep 26, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION OF THE UNRUPTURED ANEURYSM OF BASILAR ARTERY (BA)-TOP, THE MICROCATHETER WAS GUIDED TO THE TARGET SITE AND THE SUBJECT COIL WAS INSERTED AS THE FIRST COIL. PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE SUBJECT COIL INSIDE THE MICROCATHETER. DURING THE REPOSITIONING OF THE SUBJECT COIL TO ENGAGE IN THE VESSEL, THE DELIVERY WIRE LOST ITS OPERABILITY. ON WITHDRAWAL, THE SUBJECT COIL WAS FOUND PREMATURELY DETACHED INSIDE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17815104 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING C6 ANEURYSM CASE. USED STRYKER CATHETER TO DELIVER THE STENT TO HALF-DEPLOY, DELIVERED COILS AND THEN DEPLOYED THE STENT COMPLETELY. AT THE SAME TIME INSERTED THE LAST COIL (SUBJECT DEVICE) WITH CROSSING TECHNIQUE BUT THE STENT GOT STUCK AT TIP OF CATHETER USED AND THE COIL (SUBJECT DEVICE) STUCK AT TIP OF CATHETER. THE PRODUCTS COULD NOT BE WITHDRAWN SO THE OPERATOR USED A BALLOON TO GET THE STENT AND THE COIL (SUBJECT DEVICE) BACK AND PREPARED TO ARRANGE ANOTHER SURGERY TO DO THE EMBOLIZATION. PATIENT WAS SENT BACK HOME AND WAITING FOR NEXT SURGERY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899880 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION USING THE COIL (SUBJECT DEVICE), INTRAOPERATIVE RUPTURE OCCURRED AND THE PATIENT EXPERIENCED AN INTRACRANIAL HEMORRHAGE. THE PATIENT'S OUTCOME WAS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE

  Patient problems: Intracranial Hemorrhage; Ruptured Aneurysm

  MAUDE report 15749955 ↗
• MalfunctionJun 2, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE THERE WAS RESISTANCE WHEN THE SUBJECT COIL WAS ADVANCED THROUGH THE MIDDLE OF THE MICROCATHETER. THE SUBJECT COIL GOT STRETCHED AND PREMATURELY DETACHED AFTER REPEATED REPOSITIONING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14579986 ↗
• InjuryJul 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT STENT-ASSISTED ENDOVASCULAR ANEURYSMAL COIL EMBOLIZATION PROCEDURE WAS PERFORMED FOR ACOMA (ANTERIOR COMMUNICATING ARTERY) WIDE NECK LOBULATED RUPTURE ANEURYSM. THE PATIENT WAS REPORTED TO HAVE MODERATELY TORTUOUS VASCULAR ANATOMY. DURING THE PROCEDURE GUIDE CATHETER WAS PLACED TO THE RIGHT ICA (INTERNAL CAROTID ARTERY) C2 SEGMENT AND THE OPERATOR USED GUIDEWIRE FOR PLACING MICROCATHETER AT A2 FOR USED. THEN NEW MICROCATHETER WAS PLACED TO SUPER SELECTED TO THE LUMEN OF ANEURYSM AND ANEURYSMAL COIL EMBOLIZATION WAS PERFORMED. STENTING WAS PERFORMED TO COVER THE NECK OF THE ANEURYSM. WHEN THE OPERATOR TRIED TO DO COIL EMBOLIZATION WITH THE SUBJECT COIL POST STENTING, WHILE ADJUSTING EMBOLIZATION BEFORE DETACHMENT, THE SUBJECT COIL STRETCHED AND FRACTURED IN THE PATIENT'S VESSEL. ACCORDING TO THE PHYSICIAN THE SUBJECT COIL MAY BE AFFECTED BY THE STENT CELLS. THE PHYSICIAN HAS USED A SNARE DEVICE USING A MICRO GUIDE WIRE AND SURGICAL SUTURES TO REMOVE MOST OF THE PARTS OF THE DETACHED COIL FROM THE PATIENT ANATOMY. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135676 ↗
• MalfunctionMar 16, 2021Premature Separation; Premature Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497048 ↗
• MalfunctionDec 9, 2020Fracture; Fracture

  IT WAS REPORTED THAT A COIL (SUBJECT DEVICE) FAILED TO DETACH WHEN AN ATTEMPT WAS MADE TO DETACH IT WITH A DETACHMENT SYSTEM. THE TAIL OF THE DELIVERY WIRE WAS WAS FOUND FRACTURED WHEN THE SUBJECT COIL WAS REMOVED DURING THE PROCEDURE. 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 10974155 ↗
• MalfunctionNov 24, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL DEPLOYED PREMATURELY WHILE IT WAS INSIDE THE MICRO CATHETER. THE SUBJECT COIL WAS COMPLETELY REMOVED FROM THE PATIENT¿S ANATOMY AND REPLACED WITH A SIMILAR DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897248 ↗
• MalfunctionJan 27, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE UPON INSERTING THE 6TH COIL (SUBJECT DEVICE), THE PHYSICIAN FELT RESISTANCE AND IDENTIFIED THAT THE COIL HAD DETACHED WITHIN THE MICROCATHETER WITHOUT THE USE OF A POWER SUPPLY DEVICE. THE PHYSICIAN PROCEEDED TO REMOVE AND EXCHANGE BOTH THE SUBJECT DEVICE AND MICROCATHETER. THE PROCEDURE CONTINUED AND COMPLETED WITHOUT CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9635294 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE STENT ASSISTED COIL EMBOLIZATION PROCEDURE, THE PATIENT EXPERIENCED HEADACHE WHICH RESOLVED WITHOUT RESIDUAL EFFECT THE NEXT DAY. POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A MRS OF 0. ALSO, THE ANEURYSM OCCLUSION STATUS POST PROCEDURE WAS ASSESSED AS COMPLETE OBLITERATION, NO OPACIFICATION OF THE ANEURYSM OR NECK, (LEAVING NECK TO PRESERVE BRANCH IS CONSIDERED MODIFIED CLASS I). THE STUDY FACILITY ASSESSED THE HEADACHE AS BEING POSSIBLY RELATED TO THE STENT AND PROCEDURE; HOWEVER, UNKNOWN TO THE IMPLANTED COILS (SUBJECT DEVICE) AND MICROCATHETERS. DURING FOLLOW UP VISITS AT 2, 6, AND 12 MONTHS POST THE INDEX PROCEDURE, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6932976 ↗
• MalfunctionSep 29, 2017Break; Break

  IT WAS REPORTED THAT THE PROXIMAL PART OF THE COIL DELIVERY WIRE BROKE WHEN IT WAS BEING TAKING OUT FROM THE INTRODUCER SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6906168 ↗
• InjurySep 19, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL DETACHED PREMATURELY. THE PHYSICIAN DEPLOYED A STENT TO SECURE THE COIL TO THE VESSEL WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5960131 ↗
• InjuryMay 23, 2016Break; Migration or Expulsion of Device; Premature Activation; Break; Migration or Expulsion of Device; Premature Activation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM, THE PHYSICIAN FELT RESISTANCE WHILE REPOSITIONING THE SUBJECT COIL. THE SUBJECT COIL BECAME ENTANGLED WITH THE PREVIOUS COIL ALREADY IN PLACE IN THE ANEURYSM, PREMATURELY DETACHED OR BROKE AND STRETCHED INSIDE THE PATIENT. DIFFERENT UNSUCCESSFUL ATTEMPTS WERE MADE TO EITHER PUSH BACK THE COIL INTO THE ANEURYSM OR CAPTURE THE DISTAL PART OF THE COIL. THE BROKEN SUBJECT COIL WAS PROTRUDING FROM THE ANEURYSM INTO THE INTERNAL CAROTID ARTERY. THE SUBJECT COIL WAS RETRIEVED BY A SNARE DEVICE DRAGGING THE PREVIOUSLY IMPLANTED COIL OUT OF THE ANEURYSM. BOTH COILS WERE REMOVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5673830 ↗
• MalfunctionMay 18, 2016Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, THE SUBJECT COIL WAS STRETCHED AND BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5665394 ↗