TARGET M0035421530Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04546540697943), received between Nov 16, 2016 and May 20, 2026 — classified as 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL PREMATURELY DETACHED WHILE INSIDE THE CATHETER. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25230511 ↗
• MalfunctionAug 15, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE SUBJECT COIL PROXIMAL MARKER WAS MISSING DURING THE PROCEDURE. 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 22820058 ↗
• MalfunctionFeb 5, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COILING PROCEDURE, THE COIL (SUBJECT DEVICE) DETACHED PREMATURELY DURING USE. THE COIL (SUBJECT DEVICE) COULD NOT BE REMOVED FROM THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THERE WAS A SURGICAL DELAY OF 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647464 ↗
• MalfunctionSep 13, 2023Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT SUBJECT MAIN COIL WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741952 ↗
• MalfunctionAug 31, 2023Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. 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 17667487 ↗
• MalfunctionJul 24, 2023Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE, ANEURYSM TREATMENT THE SUBJECT COIL PREMATURELY DETACHED IN THE CATHETER. THE SUBJECT COIL AND CATHETER 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 17376207 ↗
• MalfunctionJun 13, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION CASE, THE OPERATOR USED A MICROCATHETER TO PLACE THE FIRST COIL. WHEN PLACING THE SECOND COIL, THE OPERATOR REPORTED THAT THE DELIVERY FORCE WAS MISSING AND CONFIRMED THAT THE COIL WAS STRETCHED. THE OPERATOR WITHDREW THE MICROCATHETER AND SECOND COIL AND THE FIRST COIL WAS UNEXPECTEDLY REMOVED, AS IT WAS TANGLED WITH THE SECOND COIL. THE OPERATOR REPLACED THE MICROCATHETER WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17116341 ↗
• MalfunctionMay 9, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT THE SUBJECT COIL DETACHED PREMATURELY DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898507 ↗
• MalfunctionMar 1, 2023Fracture; Premature Separation; Fracture; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL WOULD NOT DETACH. WHEN THE PHYSICIAN RE-POSITIONED THE SUBJECT COIL, IT DEVIATED FROM THE MASS AND THE PROXIMAL END OF THE DELIVERY WIRE WAS BROKEN OFF. THE SUBJECT COIL WAS REMOVED AND REPLACED WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464712 ↗
• MalfunctionDec 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DISTAL OF THE DELIVERY COIL BROKE AFTER AN ATTEMPT TO DEPLOY. 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 16075379 ↗
• MalfunctionAug 12, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL COULD NOT BE ADVANCED WITHIN THE MICROCATHETER DUE TO RESISTANCE AT THE PROXIMAL PART OF THE MICROCATHETER, AND THE PROXIMAL PART OF THE SUBJECT COIL WAS PREMATURELY DETACHED AT THE TIME OF REMOVAL. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215621 ↗
• MalfunctionJul 25, 2022Fracture; Fracture

  IT WAS REPORTED DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT BLEEDING DUE TO DISSECTION OF SPINAL MUSCULAR ATROPHY (SMA) BRANCH, THE SUBJECT COIL WAS INSERTED INTO THE MICROCATHETER. THE DELIVERY WIRE OF THE SUBJECT COIL WAS KINKED AND DETACHED WHEN IT WAS INSERTED INTO THE COIL DETACHMENT DEVICE. THE BROKEN DELIVERY WIRE WAS REMOVED FROM THE DETACHMENT DEVICE AND SUBJECT COIL WAS REMOVED FROM THE PATIENT¿S ANATOMY. 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 15095056 ↗
• MalfunctionJul 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT COIL BROKE INSIDE THE MICROCATHETER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 14989134 ↗
• MalfunctionMay 13, 2022Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14390133 ↗
• MalfunctionFeb 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE THE COIL (SUBJECT DEVICE) WOULD NOT ADVANCE OR RETRACT THROUGH THE SL-10 MICROCATHETER. THE COIL (SUBJECT DEVICE) GOT BROKEN IN THE PROXIMAL END OF THE MICROCATHETER AND PREMATURELY DETACHED IN THE MICROCATHETER HUB. 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 13503010 ↗
• MalfunctionSep 15, 2021Migration; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WHICH HAD BEEN PREVIOUSLY DETACHED AND PLACED IN THE ANEURYSM SUCCESSFULLY, BECAME ENTANGLED WITH THE SECOND COIL THAT WAS INSERTED INTO THE ANEURYSM. WHEN AN ATTEMPT WAS MADE TO RE-POSITION THE SECOND COIL, IT STARTED JAMMING WITH THE SUBJECT COIL. THE PHYSICIAN TRIED TO PULL OUT THE SECOND COIL BUT IT CAME OUT WITH THE SUBJECT COIL FROM INSIDE THE ANEURYSM BACK INTO THE MICROCATHETER. THE PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12476248 ↗
• InjuryJun 9, 2021Migration; Migration

  IT WAS REPORTED THAT PRE-OPERATIVE ENDOVASCULAR TUMOR EMBOLIZATION FOR THE MIDDLE MENINGEAL ARTERY PROCEDURE WAS PERFORMED BEFORE BRAIN TUMOR RESECTION. DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THREE BRANCHED BLOOD VESSELS WERE EMBOLIZED IN THE MIDDLE MENINGEAL ARTERY BY USING EMBOSPHERE (EMBOLIC MATERIAL) AND FOUR COILS. DURING ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, WHILE ADVANCEMENT OF THE SUBJECT COIL INTO THE DISTAL PORTION OF THE MICROCATHETER, RESISTANCE WAS NOTED. AFTER PLACEMENT OF THE SUBJECT COIL AT THE EMBOLIC SITE, THE SUBJECT COIL WAS DETACHED AND DETACHMENT WAS ALSO CONFIRMED UNDER FLUOROSCOPY. WHILE REMOVAL OF THE COIL DELIVERY WIRE POST DETACHMENT, SUBJECT PROXIMAL PORTION OF THE SUBJECT COIL WAS PULLED BACK WITH THE DELIVERY WIRE INTO THE MICROCATHETER. COIL DELIVERY WIRE WAS REMOVED BUT COIL WAS STILL ATTACHED TO THE MICROCATHETER. FOUR ATTEMPTS ARE MADE TO PLACED THE SUBJECT COIL FROM MICROCATHETER TO THE EMBOLIC SITE USING GUIDEWIRE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967463 ↗
• MalfunctionJun 7, 2021Premature Separation; Premature Separation

  IT WAS INITIALLY REPORTED THAT DURING THE PROCEDURE, THE COIL (SUBJECT DEVICE) ENCOUNTERED FRICTION IN THE DELIVERY WIRE AT HAND WHEN PULLING OUT THE DELIVERY SHEATH FROM THE DELIVERY WIRE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THE REPORTED EVENT. ANALYSIS OF THE RETURNED COIL (SUBJECT DEVICE) REVEALED THAT THE MAIN COIL WAS PREMATURELY DETACHED 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 11952832 ↗
• MalfunctionFeb 10, 2021Fracture; Fracture

  INITIALLY THE COMPLAINT WAS REPORTED FOR THE SUBJECT MAIN COIL FAILED/UNABLE TO DETACHED. ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL WAS BROKE/FRACTURED DURING USE. 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 11311684 ↗
• MalfunctionApr 24, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL FAILED TO DETACH. THE PHYSICIAN RE-INSERTED THE SUBJECT COIL IN THE MICRO CATHETER, BUT IT PRE-MATURELY DETACHED IN THE MICRO CATHETER. THE PHYSICIAN COMPLETED THE PROCEDURE SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996944 ↗
• MalfunctionMar 30, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED INSIDE THE MICROCATHETER. BOTH THE MICROCATHETER AND THE COIL WERE REMOVED AND REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897537 ↗
• MalfunctionFeb 13, 2020Separation Failure; Separation Failure

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED/SEPARATED INSIDE THE PATIENT'S ANATOMY DURING PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9709202 ↗
• MalfunctionJul 30, 2019Break; Break

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT MAIN COIL WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8843534 ↗
• MalfunctionMay 22, 2019Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL WAS PREMATURELY DETACHED INSIDE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8634203 ↗
• MalfunctionMay 9, 2019Physical Resistance/Sticking

  THE TARGET COILS WOULD NOT GO THROUGH THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8594878 ↗