TARGET M0036181240Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327128307), received between May 31, 2018 and Apr 8, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (16 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT COIL THROUGH THE MICROCATHETER. WHEN THE SUBJECT COIL WAS REPOSITIONED SEVERAL TIMES WITHIN THE SHAFT, THE SUBJECT COIL GOT PREMATURELY DETACHED IN THE SHAFT. THE ENTIRE MICROCATHETER WAS REMOVED FROM THE BODY, AND THE SUBJECT COIL WAS REMOVED FROM THE MICROCATHETER. THE SUBJECT COIL WAS REPLACED WITH A NEW ONE OF THE SAME KIND, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820264 ↗
• MalfunctionDec 11, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE OPERATOR WAS REPOSITIONING THE SUBJECT COIL TO ENGAGE WITH THE VESSEL. HOWEVER, THE SUBJECT COIL GOT 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 23783839 ↗
• MalfunctionOct 21, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING RUPTURED ANEURYSM PROCEDURE, THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE SUBJECT DEVICE WAS REMOVED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353508 ↗
• MalfunctionApr 15, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) GOT DETACHED WITHIN 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 21841153 ↗
• MalfunctionApr 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE MICROCATHETER KICKBACK OF THE SUBJECT COIL WAS OBSERVED. THE OPERATOR ATTEMPTED TO RIDE MICROCATHETER BACK OVER THE SUBJECT COIL TO REGAIN POSITION. HOWEVER, DURING THIS ATTEMPT THE SUBJECT COIL GOT KINKED AND STRETCHED. DELIVERY PUSHER WIRE (DPW WAS REMOVED AND THE SUBJECT COIL BROKE. FOUR SALINE INJECTIONS WERE USED TO PUSH THE SUBJECT COIL OUT OF THE CATHETER SUCCESSFULLY. 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 21748610 ↗
• MalfunctionOct 29, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE INTERNAL PORTOSYSTEMIC DYSFUNCTIONAL ANEURYSM (IPDA) PROCEDURE, THE SUBJECT COIL GOT STUCK IN THE MIDDLE OF THE MICROCATHETER SHAFT, SO ENTIRE MICROCATHETER WAS RETRIEVED. WHEN ATTEMPTED TO REMOVE THE SUBJECT COIL FROM THE MICROCATHETER, THE COIL GOT DETACHED. 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 20559681 ↗
• MalfunctionMar 28, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE OPERATOR DELIVERED THE MICROCATHETER INTO THE SPLENIC ARTERY ANEURYSM. AFTER ONE COIL WAS PLACED, THE SUBJECT COIL WAS DELIVERED AND PART OF IT WAS PLACED INTO ANEURYSM. HOWEVER, WHEN THE SUBJECT COIL WAS PULLED BACK FOR REPOSITIONING, IT PREMATURELY DETACHED. THE REMAINING SUBJECT COIL WAS PUSHED INTO THE ANEURYSM BY FLUSHING. AFTER THIS FOUR MORE COILS WERE PLACED INTO ANEURYSM. 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 18990379 ↗
• MalfunctionJul 27, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS PLACED IN THE RENAL ANEURYSM BUT THE MICROCATHETER KICKED BACK FROM THE TARGET SITE AND DEVIATED TO THE VESSEL. THE OPERATOR DECIDED TO RETRIEVE THE SUBJECT COIL AND DURING THE RETRIEVAL, THE SUBJECT COIL DETACHED INSIDE THE MICROCATHETER AND GOT STRETCHED. THE SUBJECT COIL REMAINED IN THE MICROCATHETER AND WAS COMPLETELY REMOVED BY PULLING THE SUBJECT COIL. 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 17406197 ↗
• InjuryMar 15, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ENDOVASCULAR COIL EMBOLIZATION PROCEDURE IN A PATIENT WITH SPLENIC ARTERY ANEURYSM, WHEN THE SUBJECT COIL WAS ABOUT 5 CM OUT FROM THE TIP OF THE MICROCATHETER, IT WAS PULLED BACK FOR REPOSITIONING, RESULTING IN PREMATURE DETACHMENT. THE ENTIRE MICROCATHETER WAS REMOVED, BUT THE DETACHED COIL REMAINED INSIDE THE ANEURYSM TOWARD THE GUIDE CATHETER AND HAD TO BE RETRIEVED WITH A SNARE DEVICE. THE COIL WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547825 ↗
• MalfunctionAug 3, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PULMONARY ARTERIOVENOUS MALFORMATION EMBOLIZATION, THE SUBJECT COIL WAS USED AS THE 11TH COIL. PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE SUBJECT COIL FROM THE INTRODUCER SHEATH AND ALSO AT THE TIP OF THE MICROCATHETER. HE DECIDED TO RETRIEVE THE SYSTEM, WHILE DOING SO THE SUBJECT COIL DETACHED PREMATURELY AT THE PROXIMAL END OF THE MICROCATHETER. THE SUBJECT COIL WAS TAKEN OUT 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 15156880 ↗
• MalfunctionApr 8, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED/SEPARATED INSIDE THE MICROCATHETER BEFORE ENERGIZING THE INZONE. 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 14053918 ↗
• MalfunctionMar 30, 2022Migration; Migration

  IT WAS REPORTED THAT DURING COILING BY DUAL CATHETER, AFTER THE SUBJECT COIL PLACEMENT, THE SUBJECT COIL MIGRATED AND BECAME ENTANGLED WHEN INSERTING A COIL OF THE SAME SIZE FROM ANOTHER MICROCATHETER. AN ATTEMPT WAS MADE TO RETRIEVE THE SUBJECT COIL, THEN THE COIL GOT STRETCHED. 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 13946033 ↗
• InjuryJan 13, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUBJECT COIL ENCOUNTERED RESISTANCE WHILE INSERTING INSIDE THE MICROCATHETER. BOTH SUBJECT COIL AND THE MICROCATHETER WERE ATTEMPTED TO REMOVE BUT THE SUBJECT COIL PREMATURELY DETACHED INSIDE THE PATIENT'S ANATOMY. THE SUBJECT COIL WAS ATTEMPTED TO REMOVE BUT IT STRETCHED AND REMAINED INSIDE THE BODY. THE PHYSICIAN HAS NO PLANS TO REMOVE THE SUBJECT COIL FROM THE PATIENT'S ANATOMY. CONDITION OF THE PATIENT, HOW PROCEDURE WAS COMPLETED AND ANY MEDICAL INTERVENTION DONE DUE TO THIS EVENT ARE UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11161993 ↗
• MalfunctionJan 7, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN TRIED TO INSERT THE SUBJECT COIL INTO THE MICRO CATHETER. THE SUBJECT COIL 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 11136762 ↗
• InjurySep 24, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SUBJECT COIL WAS UNABLE TO DETACH. IT WAS PULLED AND IT STRETCHED. THE PHYSICIAN ATTEMPTED TO REMOVE THE SUBJECT COIL USING A SNARE BUT IT PREMATURELY DETACHED. HOWEVER, IT WAS SUCCESSFULLY REMOVED FROM THE PATIENT ANATOMY. DURING THIS EVENT, THE SUPERIOR MESENTERIC ARTERY WAS PARTIALLY INJURED AND AN UNKNOWN STENT GRAFT WAS USED AS TREATMENT. THE PHYSICIAN COMPLETED THE PROCEDURE SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 10584289 ↗
• MalfunctionJun 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL (SUBJECT DEVICE) WAS ATTEMPTED TO INSERT, THE RESISTANCE BECAME STRONGER GRADUALLY, THEREFORE, THE COIL (SUBJECT DEVICE) WAS REMOVED AND FLUSHED WITHIN THE MICROCATHETER. BLOOD OF THE COIL (SUBJECT DEVICE) WAS WASHED IN A TRAY OUTSIDE THE PATIENT' S BODY AND ATTEMPTED TO REINSERT THE COIL. AT THAT TIME, THE SURGEON FELT SHAPE OF THE COIL (SUBJECT DEVICE) WAS BROKEN AND CONSIDERING IT WAS STRETCHED. THE COIL (SUBJECT DEVICE) WAS DISCONTINUED TO USED. THE PRODUCT WAS EXCHANGED WITH THE SAME NEW ONE AND THE PROCEDURE CONTINUED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10166115 ↗
• MalfunctionApr 30, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL (SUBJECT DEVICE) COULDN'T BE PULLED OR PUSHED WHILE ADVANCING INSIDE A MICROCATHETER. WHEN THE SUBJECT COIL WAS REMOVED, IT WAS FOUND TO BE PREMATURELY DETACHED INSIDE THE MICROCATHETER. 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 10014398 ↗
• MalfunctionDec 17, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE WHILE TRYING TO PLACE THE THIRD COIL (SUBJECT DEVICE), EARLY DETACHMENT OCCURRED WHILE INSERTING AND PULLING BACK. THE COIL WAS COLLECTED WITHIN THE MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171679 ↗
• MalfunctionOct 18, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION THE WHEN ADVANCING THE SUBJECT COIL THROUGH (NON -STRYKER) MICROCATHETER, THE COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE DETACHED COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER AND WAS EXCHANGED WITH ANOTHER NEW COIL. NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7982079 ↗
• MalfunctionMay 31, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN THE COIL WAS ADVANCED IN THE MICROCATHETER, THE COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. 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 7558015 ↗