TARGET M0035442040Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 07613252600299), received between May 18, 2016 and Aug 20, 2025 — classified as 10 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (25 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE WHEN THE SUBJECT COIL WAS INSERTED INTO THE CATHETER, ONLY HALF OF THE DEVICE WAS ABLE TO ADVANCE. THE COIL WAS FOUND PREMATURELY DETACHED, STUCK HALF IN CATHETER. 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 22850586 ↗
• MalfunctionDec 5, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE NEUROVASCULAR PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE COIL (SUBJECT DEVICE) WITHIN THE MICROCATHETER AND IT WAS DIFFICULT TO ADVANCE. WHEN THE COIL (SUBJECT DEVICE) WAS PULLED BACK IT DETACHED PREMATURELY WITHIN THE MICROCATHETER. THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266725 ↗
• MalfunctionNov 22, 2023Fracture; Fracture

  IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE DURING COIL (SUBJECT DEVICE) PLACEMENT IN THE ANEURYSM AND THE COIL (SUBJECT DEVICE) GOT STUCK. UPON REMOVAL OF THE MICROCATHETER, A SMALL PIECE WAS NOTICED SEPARATED FROM THE SUBJECT COIL (COLLECTED). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196162 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS DETACHED BUT THE PROXIMAL END WAS CAUGHT ON THE TIP OF THE MICROCATHETER. AN ADDITIONAL DEVICE WAS USED AS A MEDICAL INTERVENTION TO FORCE THE SUBJECT COIL OFF 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 17719863 ↗
• InjuryMay 25, 2023Expulsion; Premature Separation; Expulsion; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS ATTEMPTED TO BE DETACHED USING THE POWER SUPPLY, BUT THE SUBJECT COIL DID NOT FULLY DETACH. THE PHYSICIAN NOTICED THIS AS HE PULLED BACK ON THE DELIVERY WIRE TO ENSURE DETACHMENT. FOLLOWING THIS, AFTER MICROCATHETER MOVEMENTS, THE COIL DETACHED FULLY WITHOUT AN ADDITIONAL ATTEMPT TO DETACH WITH THE POWER SUPPLY. THIS LEFT A PORTION OF THE COIL PROTRUDING INTO THE PARENT VESSEL. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL WITH THE SNARE BUT WAS UNSUCCESSFUL AND LEFT THE COIL WITH PARTIAL TAIL HANGING INTO THE PARENT VESSEL (ANTERIOR CEREBRAL ARTERY). NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001042 ↗
• MalfunctionDec 16, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE MICROCATHETER WAS PLACED AT THE TARGET SITE AND THE SUBJECT COIL WAS INSERTED. THE SUBJECT COIL BECOME STUCK AND PREMATURELY DETACHED IN THE MICROCATHETER. THE SUBJECT COIL WAS REMOVED WITH THE ENTIRE MICROCATHETER FROM THE PATIENTS BODY. THE PHYSICIAN REPLACED THE COIL WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996933 ↗
• MalfunctionDec 1, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL STUCK IN THE MICROCATHETER AND WHEN THE DELIVERY WIRE WAS PULLED IT GOT PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE SUBJECT COIL WAS REMOVED ALONG WITH THE MICROCATHETER. BOTH DEVICES WERE REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893322 ↗
• MalfunctionOct 24, 2022Premature Separation; Premature Separation

  DURING COIL EMBOLIZATION OF SUPERIOR MESENTERIC ARTERY FOR GASTROINTESTINAL BLEEDING, THE SUBJECT COIL HAD RESISTANCE WHILE ADVANCING PAST THE INTRODUCER SHEATH. THE PHYSICIAN SUCCESSFULLY DELIVERED THE SUBJECT COIL INTO THE LESION. WHEN DETACHMENT WAS ATTEMPTED, THE SUBJECT COIL FAILED TO DETACH. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE SUBJECT COIL ALONG WITH THE MICROCATHETER, THE SUBJECT COIL DETACHED PREMATURELY INTO THE INTENDED VESSEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657911 ↗
• MalfunctionAug 5, 2022Premature Separation; Premature Separation

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE 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 15176294 ↗
• MalfunctionJul 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE RESISTANCE ENCOUNTERED WHEN INSERTING THE SUBJECT COIL INTO THE MICROCATHETER AND THE DELIVERY WIRE OF THE SUBJECT COIL WAS COMPLETELY TORN FROM THE FLUORO-SAVER MARKER PART. RECALLED AS THE BREAKAGE WAS ABNORMAL, AND THE SUBJECT COIL WAS NO LONGER USABLE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14935481 ↗
• MalfunctionDec 16, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS DETACHED PREMATURELY INSIDE THE MICROCATHETER . THE SUBJECT COIL WAS EXTRACTED ALONG WITH 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 13019333 ↗
• MalfunctionNov 29, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN ANEURYSM COILING PROCEDURE WAS PERFORMED IN A PATIENT. DURING THE PROCEDURE A MICROCATHETER WAS USED TO REACH THE TARGET LESION. THE SUBJECT COIL WAS THE FIRST COIL WHICH WAS ATTEMPTED TO BE DELIVERED THROUGH THE MICROCATHETER TO THE TARGET LESION. WHEN ADVANCING THE SUBJECT COIL THROUGH THE MICROCATHETER, THE SUBJECT COIL DETACHED PREMATURELY INTO THE LUMEN OF THE MICROCATHETER. WHEN THE SUCCESSIVE SECOND AND THIRD COIL WERE ATTEMPTED TO BE INSERTED INTO THE SAME MICROCATHETER WITHOUT NOTICING THE PREMATURELY DETACHED FIRST SUBJECT COIL, THE SUCCESSIVE COIL'S COULD NOT BE INTRODUCED INTO THE MICROCATHETER. THE SUBJECT COIL ALONG WITH THE MICROCATHETER WERE RETRIEVED OUT OF THE PATIENT'S BODY. 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 12883884 ↗
• MalfunctionNov 11, 2021Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL WAS PREMATURELY DEPLOYED 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 12793204 ↗
• MalfunctionNov 3, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE ANEURYSM COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE SUBJECT COIL INSIDE THE DISTAL PART OF THE MICROCATHETER. ON WITHDRAWAL, THE SUBJECT COIL WAS DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE PREMATURELY DEPLOYED SUBJECT COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. 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 12747513 ↗
• MalfunctionOct 20, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND 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 12669764 ↗
• MalfunctionSep 28, 2021Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL PREMATURELY DETACHED/SEPARATED 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 12544238 ↗
• MalfunctionSep 5, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION FOR SAH, THE SUBJECT COIL WAS USED AS THE FOURTH COIL. THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE SUBJECT COIL IN THE MIDDLE OF THE MICROCATHETER SHAFT. WHEN HE ATTEMPTED TO REMOVE THE SUBJECT COIL FROM THE MICROCATHETER, THE PROXIMAL PART OF THE SUBJECT COIL GOT STRETCHED AND A PART OF IT BROKE AND REMAINED INSIDE THE MICROCATHETER. THE MICROCATHETER WAS REMOVED ALONG WITH THE BROKEN PART OF THE SUBJECT COIL FROM THE PATIENT¿S ANATOMY. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12426337 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO INSERT THE SUBJECT COIL INTO THE ANEURYSM, IT GOT STRETCHED AND IT WAS REMOVED USING A SNARE DEVICE. NO EXCESSIVE FORCE WAS APPLIED. 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 12229881 ↗
• MalfunctionJun 30, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ACOM ANEURYSM EMBOLIZATION CASE, PHYSICIAN PREPARED A MICRO CATHETER TO FILL THE COIL BUT ON CHECKING, HE FOUND THAT INTRODUCER SHEATH OF THE COIL WAS KINKED. HE TRIED TO PUSH THE COIL BUT WAS UNABLE TO TRANSFER IT INTO THE MICRO CATHETER. THE COIL WAS WITHDRAWN AND REPLACED WITH THE ANOTHER COIL BUT HE WAS STILL NOT ABLE TO INSERT THE COIL. PHYSICIAN EXCHANGED THE MICRO CATHETER AND TRIED TO INSERT THE NEW COIL BUT WAS UNABLE TO DO SO. HE THEN TOOK THE SUBJECT COIL AND INSERTED, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE COIL INSIDE THE MICRO CATHETER AND THE COIL GOT STRETCHED AND FRACTURED. IT WAS REMOVED ALONG WITH THE MICRO CATHETER. 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 12095320 ↗
• MalfunctionMay 11, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE PHYSICIAN WAS DEPLOYING THE SUBJECT COIL, IT DETACHED PREMATURELY INSIDE THE MICRO CATHETER. 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 11809371 ↗
• MalfunctionApr 21, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS UNABLE TO GO OUT OF THE SHEATH EVEN AFTER SEVERAL ATTEMPTS TO PUSH IT OUT. WHEN THE PHYSICIAN TRIED TO PUSH IT FORCEFULLY, IT DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED AND REPLACED THE DEVICE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704560 ↗
• MalfunctionApr 6, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DEPLOYED WHILE IT WAS APPROXIMATELY 1/3 INTO THE MICROCATHETER. THE PHYSICIAN REPLACED THE SUBJECT DEVICE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625611 ↗
• MalfunctionMar 19, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, A COIL (SUBJECT DEVICE) ENCOUNTERED RESISTANCE INSIDE THE MIDDLE PART OF THE MICROCATHETER. THE PHYSICIAN MADE AN ATTEMPT TO COLLECT THE SUBJECT COIL BUT WHEN THE IT WAS BROUGHT TO THE PROXIMAL PART OF THE MICROCATHETER, IT WAS FOUND THAT THE SUBJECT MAIN COIL WAS NOT ATTACHED AT THE TIP OF ITS DELIVERY WIRE. THE PHYSICIAN SEARCHED THE SURGICAL FIELD, ALL THE OTHER CONJUNCTION DEVICES AND INSIDE THE PATIENT'S SKULL BUT COULD NOT FIND IT. THE PHYSICIAN REMOVED THE MICROCATHETER AND FLUSHED THE LUMEN OUTSIDE THE PATIENT'S ANATOMY BUT THE SUBJECT COIL DID NOT COME OUT OF THE MICROCATHETER. THE PHYSICIAN DELIVERED A GUIDEWIRE INSIDE THE MICROCATHETER BUT IT GOT CAUGHT AT THE PROXIMAL END OF 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 11531861 ↗
• MalfunctionFeb 10, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE SUBJECT COIL WAS ADVANCING UP THROUGH THE MICROCATHETER. WHILE IN THE MICROCATHETER SUBJECT COIL EXPERIENCED RESISTANCE AND DID NOT REACH THE ANEURYSM. PHYSICIAN PROCEEDED TO REMOVE COIL ONLY TO FIND THAT THE SUBJECT COIL HAD BEEN PREMATURELY DETACHED FROM THE DELIVERY WIRE WITHIN MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11311467 ↗
• MalfunctionFeb 5, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ENDOVASCULAR (ANEURYSMAL) COIL EMBOLIZATION PROCEDURE, DURING ADVANCEMENT OF THE COIL IN THE MICROCATHETER (MID COILING) THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED IN THE LUMEN OF THE MICROCATHETER. THE OPERATOR REMOVED THE MICROCATHETER ALONG WITH PREMATURELY DETACHED COIL FROM THE PATIENT VASCULATURE COMPLETELY. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE, ACCESS INTO THE ANEURYSM WAS REGAINED AND COILING CONTINUED. 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 11283748 ↗