TARGET M0036181450Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327128383), received between Apr 18, 2017 and Apr 19, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER DURING THE PROCEDURE. 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 21870022 ↗
• MalfunctionJan 31, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE WHEN THE SUBJECT COIL WAS ADVANCED IN THE MICROCATHETER THERE WAS RESISTANCE AND ONE SUBJECT COIL PREMATURELY DETACHED INSIDE THE CATHETER. THE PHYSICIAN REMOVED THE SUBJECT COIL AND IT WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286899 ↗
• MalfunctionJan 16, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DISTAL END OF THE SUBJECT COIL GOT STRETCHED AND RESISTANCE WAS ENCOUNTERED ADVANCING THE SUBJECT COIL IN THE MICROCATHETER. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT MAIN COIL WAS FOUND TO BE DETACHED/SEPARATED FROM THE DELIVERY WIRE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169436 ↗
• InjuryDec 11, 2024Expulsion; Migration; Premature Separation; Expulsion; Migration; Premature Separation

  IT WAS REPORTED DURING AN INTRINSIC HEPATIC ARTERY ANEURYSM CASE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING SUBJECT COIL IN THE SHAFT OF MICROCATHETER. THE SUBJECT COIL ENCOUNTERED DIFFICULTY IN ENGAGING WITH THE STENT AND VESSEL WALL DURING REPOSITIONING, LEADING TO THE PREMATURE DETACHMENT FROM THE COIL JUNCTION WITHIN THE VESSEL. A GOOSENECK SNARE WAS USED TO RETRIEVE THE FRACTURED COIL, BUT RETRIEVAL WAS UNSUCCESSFUL, SO THE FRACTURED COIL WAS LEFT IN THE PATIENT. SURGICAL DELAY OF 300 MINUTES WAS OBSERVED, AND PATIENT IS UNDER OBSERVATION. ADDITIONAL EMBOLIZATION OF THE ANEURYSM IS EXPECTED TO BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901876 ↗
• MalfunctionFeb 23, 2024Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE DELIVERY WIRE OF THE COIL (SUBJECT DEVICE) WAS 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 18769330 ↗
• MalfunctionDec 19, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DETACHED PREMATURELY WHILE BEING ADVANCED WITHIN THE MICROCATHETER. THE COIL WAS COMPLETELY REMOVED FROM THE PATIENTS BODY WITH THE MICROCATHETER. 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 16007550 ↗
• MalfunctionJan 4, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE COIL (SUBJECT DEVICE) WAS RETRIEVED FROM THE PATIENT IT DETACHED PREMATURELY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151139 ↗
• MalfunctionJul 5, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE SUBJECT COIL, IT DETACHED AT THE HAND PART OF THE MICROCATHTER (NON STRYKER). THE PROCEDURE WAS COMPLETED WITH OTHER PRODUCT WITHOUT ANY ISSUES. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8765118 ↗
• MalfunctionJan 4, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE COIL (SUBJECT DEVICE) WAS ADVANCED INTO 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 8220298 ↗
• MalfunctionJan 4, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE COIL (SUBJECT DEVICE) WAS ADVANCED INTO 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 8220297 ↗
• MalfunctionMay 18, 2018Break; Break

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE SUBJECT COIL DETACHED IN THE MICROCATHETER INSIDE THE PATIENT. THE CUSTOMER DID NOT MAINTAIN CONTINUOUS FLUSH AS RECOMMENDED PER DFU. THE PHYSICIAN DID NOT MAKE ANY ATTEMPTS TO DETACH THE COIL USING THE DETACHMENT SYSTEM. THE PHYSICIAN REMOVED THE DETACHED COIL TO CONTINUE WITH THE PROCEDURE. A SNARE DEVICE WAS NOT USED WHEN THE SUBJECT COIL WAS REMOVED. SIMILAR EVENT OCCURRED TO ANOTHER COIL USED IN THE PROCEDURE. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7526812 ↗
• MalfunctionApr 18, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE THE RESISTANCE WAS ENCOUNTERED AND THE COIL WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER WHEN ATTEMPTED TO BE RE-SHEATHED. THE COIL ALONG WITH THE MICROCATHETER WAS SAFELY REMOVED FROM THE PATIENT AS ONE UNIT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6502235 ↗