TARGET M0036181040Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07613327128406), received between Jul 18, 2018 and Feb 26, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (20 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Premature Separation

  IT WAS REPORTED THAT WHEN ATTEMPTING REPOSITIONING OF THE SUBJECT COIL IN THE ANEURYSM TO ENGAGE WITH THE VESSEL, IT GOT PREMATURELY DETACHED. (LOCATION OF PREMATURELY DETACHMENT IS UNKNOWN). INSERT FORCEPS INTO THE SHEATH AND RETRIEVE THEM AS A SINGLE UNIT. HEMOSTASIS WAS ACHIEVED ONCE, THE CONTRALATERAL FEMORAL ARTERY WAS PUNCTURED, AND THE PROCEDURE WAS CONTINUED WITH THE REPLACED COIL AND COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451313 ↗
• MalfunctionNov 20, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE PROXIMAL END OF MICROCATHETER WHEN THE SUBJECT COIL WAS INSERTED. ALSO, THE SUBJECT COIL GOT PREMATURELY DETACHED WITHIN THE MICROCATHETER WHEN THE PHYSICIAN ATTEMPTED TO PULL IT BACK. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610407 ↗
• MalfunctionApr 23, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE OPERATOR ENCOUNTERED RESISTANCE DURING ADVANCEMENT OF THE SUBJECT COIL IN THE MICROCATHETER'S SHAFT. WHEN THE SUBJECT COIL WAS RETRIEVED, IT WAS FOUND TO BE PREMATURELY DETACHED. 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 21895458 ↗
• MalfunctionApr 10, 2025Migration; Migration

  IT WAS REPORTED DURING THE EMBOLIZATION PROCEDURE WHEN ANOTHER COIL PREMATURELY DETACHED IN THE CATHETER AND A GUIDEWIRE WAS USED TO REMOVE IT, THE SUBJECT COIL THAT HAD BEEN IMPLANTED, CAME OUT WITH THE PREMATURELY DETACHED COIL THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21816652 ↗
• MalfunctionDec 13, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE THE COIL ( SUBJECT DEVICE) PREMATURELY DETACHED WITHIN THE 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 18321138 ↗
• MalfunctionSep 13, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, THERE WAS RESISTANCE WHILE ADVANCING THE SUBJECT COIL WITHIN THE MICROCATHETER. THE PHYSICIAN WAS PUSHING THE PUSHER WIRE IN BUT GETTING NO FEEDBACK. THE SUBJECT COIL PUSHER WIRE WAS PULLED BACK AND IT WAS FOUND THAT THE SUBJECT COIL SNAPPED OFF AND PREMATURELY DETACHED FROM THE PUSHER WIRE. THE SUBJECT COIL AND DELIVERY WIRE WERE ABLE TO BE PULLED OUT OF THE BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741775 ↗
• InjuryApr 18, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE SUBJECT COIL STRETCHED AND PREMATURELY DETACHED WHEN IT WAS BEING REPOSITIONED INSIDE OF THE PATIENT. A PIGTAIL CATHETER WAS USED TO RETRIEVE THE DETACHED COIL. 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 16761074 ↗
• MalfunctionApr 21, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE FOR PORTAL VEIN EMBOLISM, THE SUBJECT COIL WAS USED. DURING THE SUBJECT COIL PLACEMENT, THERE WAS FRICTION AT THE DISTAL MICROCATHETER SHAFT AND THE SUBJECT COIL WAS TAKEN IN AND OUT SEVERAL TIMES FOR REPOSITIONING WITHIN THE ANEURYSM, BUT IT PREMATURELY DETACHED EVEN THOUGH THERE WAS NO ATTEMPT TO DETACH WITH A DETACHMENT SYSTEM. THE SUBJECT COIL WAS COLLECTED TOGETHER WITH THE MICROCATHETER. THE SAME MICROCATHETER WAS THEN REINSERTED AND ANOTHER REPLACEMENT COIL WAS INSERTED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704651 ↗
• MalfunctionApr 21, 2021Premature Separation; Premature Separation

  ANALYSIS OF THE DEVICE REVEALED THAT THE MAIN COIL HAD PREMATURELY DETACHED/SEPARATED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704636 ↗
• MalfunctionDec 21, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL PREMATURELY DETACHED DURING THE PROCEDURE WITHOUT USE OF THE DETACHMENT SYSTEM. THE PHYSICIAN WAS ABLE TO PLACE THE SUBJECT COIL SAFELY IN THE TARGET LESION. THE PROCEDURE WAS COMPLETED SAFELY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11052945 ↗
• MalfunctionDec 17, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE OF COIL EMBOLIZATION OF INTERNAL ILIAC ARTERY, AFTER PREPARATION WHEN THE COIL (SUBJECT DEVICE) WAS ATTEMPTED TO INSERT UNDER APPROPRIATE INTERMITTED FLUSH, IT PREMATURELY DETACHED UNINTENTIONALLY (WITHOUT USING INZONE). 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 11033077 ↗
• MalfunctionJul 15, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN ATTEMPTED TO INSERT THE SUBJECT COIL BUT IT GOT STUCK INSIDE THE MICROCATHETER AND WAS UNABLE TO BE PUSHED FORWARD. SO THE PHYSICIAN DECIDED TO REMOVE IT AND WHILE REMOVING THE SUBJECT COIL DETACHED PREMATURELY SO IT WAS TAKEN OUT ALONG WITH THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10280954 ↗
• MalfunctionJul 2, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED WHILE IT WAS ATTEMPTED TO INSERT SEVERAL TIMES BY PUSHING AND PULLING INSIDE THE MICROCATHETER. THE SUBJECT COIL WAS COLLECTED WITH A SNARE DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10227292 ↗
• MalfunctionDec 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN THE COIL (SUBJECT DEVICE) WAS ADVANCED INTO THE CATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE COIL AND IT WAS FOUND BROKEN IN CATHETER. THE COIL WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490049 ↗
• MalfunctionNov 7, 2019Premature Separation; Premature Separation

  IT WAS REPORTED WHEN THE COIL WAS ADVANCED INTO THE CATHETER, RESISTANCE WAS FELT AND THE COIL WAS PREMATURELY DETACHED. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9289026 ↗
• MalfunctionNov 6, 2019Premature Separation; Premature Separation

  IT WAS REPORTED WHEN THE COIL WAS ADVANCED INTO THE CATHETER, RESISTANCE WAS FELT AND THE COIL WAS PREMATURELY DETACHED. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9288736 ↗
• MalfunctionAug 28, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE SUBJECT DEVICE (COIL) WAS PLACING, THE NON STRYKER MICROCATHETER WAS KICKED BACK REPEATEDLY, AND THE SUBJECT COIL WAS WINDED UP INSIDE OTHER COMPANY MICROCATHTER. AT THAT TIME SURGEON POINTED OUT THAT HE COULD NOT PUSH THE SUBJECT COIL. SINCE HE WAS ABLE TO RETRACT THE SUBJECT COIL, IT WAS RETRACTED AND FOUND OUT THAT THE SUBJECT COIL WAS DETACHED FROM THE COIL JUNCTION PART. THE SUBJECT COIL WAS EXCHANGED WITH OTHER COMPANY ONE. THE PROCEDURE CONTINUED AND COMPLETED WITHOUT PROBLEM. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8942543 ↗
• MalfunctionMay 17, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A HEPATIC ANEURYSM AFTER INSERTING 25 COILS (NON-STRYKER DEVICES), THE SUBJECT COIL WAS INSERTED INTO THE NON-STRYKER MICROCATHETER AND THE COIL PREMATURELY DETACHED. THE SUBJECT COIL AND THE MICROCATHETER WERE REMOVED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621864 ↗
• MalfunctionMay 14, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE COIL THROUGH THE MICROCATHETER AND THE COIL WAS PREMATURELY DETACHED. THE COIL WAS REMOVED ALONG WITH THE MICROCATHETER FROM THE PATIENT¿S ANATOMY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609724 ↗
• InjuryJan 10, 2019Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) EXPERIENCED RESISTANCE IN THE CATHETER. WHEN THE PHYSICIAN PULLED BACK THE COIL, THE COIL BECAME STRETCHED AND HAD DETACHED PREMATURELY. ADDITIONALLY, THERE MAY BE THROMBUS IN THE MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Thrombus

  MAUDE report 8233906 ↗
• MalfunctionOct 4, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, DURING REPOSITIONING, THE COIL (SUBJECT DEVICE) SLOWLY RETREATED BACK INTO THE MICROCATHETER AND PREMATURELY AND MECHANICALLY DETACHED AT THE JUNCTION ZONE. THE COIL WAS REMOVED WITH THE MICROCATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7936352 ↗
• InjurySep 6, 2018Adverse 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 FELT RESISTANCE WHILE ADVANCING THE COIL IN THE MICROCATHETER, THE COIL COULD NOT BE PUSHED OR PULLED AND THE COIL UNRAVELED NEAR THE DETACHMENT ZONE AND HAD TO BE RETRIEVED WITH A 4MM GOOSENECK SNARE. THE PHYSICIAN REPLACED IT WITH A NEW COIL AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7853542 ↗
• MalfunctionJul 18, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM LOCATED ON THE INTERNAL ILIAC ARTERY, THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED AT THE DETACHMENT ZONE. THE COIL PROXIMAL TAIL WAS STILL INSIDE THE MICROCATHETER WHEN THE PREMATURE DETACHMENT OCCURRED AND HALF OF THE COIL WAS OUTSIDE THE MICROCATHETER. THE COIL WAS REMOVED WITH THE MICROCATHETER AS ONE UNIT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7700503 ↗