TARGET M0035422060Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07613252239345), received between Oct 4, 2016 and Aug 12, 2026 — classified as 2 injuries, 27 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226032 ↗
• MalfunctionDec 18, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL HAD DIFFICULTY ADVANCING INSIDE THE CATHETER SHAFT. IT BECAME STUCK AND PREMATURELY DETACHED. 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 23846358 ↗
• MalfunctionDec 16, 2025Premature Separation; Poor Visibility; Premature Separation; Poor Visibility

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT WAS LOADED INTO THE MICROCATHETER, AND THE SUBJECT COIL WAS UNABLE TO BE SEEN UNDER FLUOROSCOPY AS THE PUSHER WIRE WAS ADVANCED, AND FURTHERMORE THE SUBJECT COIL WAS 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 23819001 ↗
• MalfunctionAug 12, 2025Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED DURING USE. 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 22784650 ↗
• MalfunctionMar 10, 2025Fracture; Fracture

  ANALYSIS AND THE RETURNED DEVICE REVEALED THAT THE SUBJECT MAIN COIL AND SUBJECT COIL DELIVERY WIRE WERE BROKEN/FRACTURED DURING USE. 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 21566091 ↗
• MalfunctionSep 9, 2024Separation Failure; Separation Failure

  ANALYSIS OF THE RETURNED DEVICE FOUND THE SUBJECT COIL TO HAVE BEEN PREMATURELY DETACHED/SEPARATED FROM THE DELIVERY WIRE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20174524 ↗
• MalfunctionJul 31, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ANEURYSM TREATMENT CASE, SUBJECT COIL GOT PREMATURELY DEPLOYED IN MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19875895 ↗
• MalfunctionMay 14, 2023Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE REVEALED, THAT THE SUBJECT COIL DETACHED PREMATURELY DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT. AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928323 ↗
• MalfunctionDec 12, 2022Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE COIL 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 15964288 ↗
• MalfunctionMay 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE THE COIL (SUBJECT DEVICE) COULD NOT DETACH. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE RETURNED DEVICE FOUND THE COIL DELIVERY WIRE BROKEN/FRACTURED. 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 14520034 ↗
• MalfunctionDec 9, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL 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 12973428 ↗
• MalfunctionNov 11, 2021Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL PREMATURELY DETACHED/SEPARATED FROM DELIVERY WIRE 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 12800918 ↗
• MalfunctionNov 4, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL WAS 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 12754467 ↗
• MalfunctionApr 21, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT COIL THROUGH THE MICROCATHETER SHAFT. WHEN THE PHYSICIAN WAS REMOVING THE COIL FROM THE MICROCATHETER, THE COIL DETACHED DUE TO THE RESISTANCE ENCOUNTERED WHILE PULLING THE COIL OUT. THE COIL AND MICROCATHETER WERE REPLACED AND THE PROCEDURE WERE COMPLETED SUCCESSFULLY. 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 11704489 ↗
• InjuryJan 21, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) COULDN'T BE DETACHED INSIDE THE ANEURYSM AND DURING RE-POSITIONING, IT GOT DETACHED PREMATURELY INSIDE THE PATIENT'S ANATOMY. A SNARE DEVICE WAS USED TO REMOVE THE DETACHED COIL 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 11208504 ↗
• MalfunctionDec 23, 2020Expulsion; Premature Separation; Expulsion; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS USED FOR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY (ICA ) JUST BELOW THE ANTERIOR CHOROIDAL ARTERY. DURING THE PROCEDURE, A STENT WAS DEPLOYED IN THE ICA JUST BELOW THE ANTERIOR CHOROIDAL ARTERY WITHOUT ANY ISSUES. WHEN ADVANCING THE FIRST COIL, RESISTANCE WAS ENCOUNTERED INSIDE THE INTRODUCER SHEATH AND WAS REPLACED WITH THE SUBJECT COIL. THE SUBJECT COIL WAS PLACED IN THE ANEURYSM WITHOUT ANY ISSUES AND WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, THE DETACHMENT SYSTEM SOUNDED 3 BEEPS WHICH IS AN INDICATION OF DETACHMENT, BUT THE SUBJECT COIL WAS NOT DETACHED. WITHDRAWING THE DELIVERY WIRE, A LOOP OF THE COIL CAME OUT THROUGH THE STENT. WHEN CHECKING UNDER FLUOROSCOPY DURING REMOVAL OF THE DELIVERY WIRE IT WAS IMPOSSIBLE TO KNOW THAT THE COIL WAS NOT DETACHED SINCE THE MICROCATHETER WAS WITHIN THE COIL MASS. AT THIS STAGE, THE PHYSICIAN TRIED TO PUSH THE DELIVERY WIRE WITH THE COIL BACK INTO THE ANEURYSM BUT UNFORTUNATELY AS THE DETACHMENT ZONE HAD BEEN WEAKENED IT DETACHED LEAVING A LOOP IN THE ICA. THERE WAS QUITE A DELAY TO THE PROCEDURE. THE FIRST ONE WAS TRYING TO ADVANCE THE COIL THROUGH THE SHEATH WHICH TOOK ABOUT 3 MINUTES A

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11068726 ↗
• MalfunctionJun 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS DELIVERED IN MICROCATHETER, BUT RESISTANCE WAS ENCOUNTERED EVEN WHEN RETRACTING. UPON REMOVAL OF SUBJECT DEVICE FROM PATIENT ANATOMY, FOUND THAT THE COIL FRACTURED FROM DELIVERY WIRE. 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 10176295 ↗
• MalfunctionJun 16, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE PROXIMAL PORTION OF THE SUBJECT COIL¿S PUSHER WIRE KINKED AND THEN BROKE WHILE BEING PUSHED INTO THE MICROCATHETER. THE PHYSICIAN TRIED TO DETACH THE SUBJECT COIL TO SEE IF IT COULD STILL BE DETACHED DESPITE BEING BROKEN AT THE PROXIMAL END. THE SUBJECT COIL WAS UNABLE TO DETACH AND WAS COMPLETELY REMOVED FROM PATIENT ANATOMY. THE PHYSICIAN REPLACED THE SUBJECT COIL WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10160104 ↗
• MalfunctionJan 24, 2020Failure to Advance

  DURING THE PROCEDURE FOR COIL EMBOLIZATION, THE TARGET COIL WOULD NOT ADVANCE INTO THE MICROCATHETER. IT DID NOT ENTER THE PATIENT, AND THERE WAS NO PATIENT HARM. MANUFACTURER RESPONSE FOR DEVICE, NEUROVASCULAR EMBOLIZATION, TARGET (PER SITE REPORTER). SENT SHIPPER KIT TO RETURN THE DEVICE TO THE MANUFACTURER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9626821 ↗
• MalfunctionJan 15, 2020Break; Break

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593296 ↗
• MalfunctionNov 8, 2019Component Misassembled; Component Misassembled

  DURING PROCEDURE, IT WAS REPORTED THAT THE SURGEON FOUND THAT THE RADIOPAQUE ALIGNMENT MARKER OF COIL DELIVERY WIRE IS LOCATED MORE PROXIMAL THAN NORMAL LOCATION. HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SUBJECT COIL IMPLANTED IN THE PATIENT'S BODY. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9301509 ↗
• MalfunctionOct 14, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT COIL FROM THE INTRODUCER SHEATH INTO THE MICROCATHETER AND WHEN THE COIL WAS REMOVED, THE TIP OF THE COIL WAS MISSING. THE OPERATOR THEN CUT THE MICROCATHETER; HOWEVER, THE COIL WAS NOT FOUND. NO PATIENT CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188772 ↗
• MalfunctionMay 22, 2019Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE COIL WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8634286 ↗
• MalfunctionApr 16, 2019Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE COIL WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519204 ↗
• MalfunctionJun 29, 2018Break; Break

  ANALYSIS OF THE RETURNED COIL REVEALED THAT THE DELIVERY WIRE WAS BROKEN. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651707 ↗