TARGET M0035452040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613252600374), received between May 6, 2016 and Nov 29, 2022 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL COULD NOT BE ADVANCED TO PROXIMAL OF MICROCATHETER EVEN AFTER SEVERAL TRIES. DURING ADVANCING IT GOT DETACHED IN 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 15880884 ↗
• MalfunctionAug 19, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE SUBJECT COIL WAS NOTED TO HAVE FRICTION UPON INSERTING INTO MICROCATHETER HUB. PHYSICIAN PROCEEDED TO MOVE COIL BACK AND RE-ADVANCED SUBJECT COIL INTO MICROCATHETER. DURING THE PROCEDURE THE SUBJECT COIL WAS THEN NOTED TO BE PREMATURELY DETACHED AT THE DETACHMENT ZONE WITHIN THE MICROCATHETER. THE SUBJECT COIL WAS RETRIEVED BY WITHDRAWING MICROCATHETER AND USING MICRO GUIDEWIRE. PHYSICIAN REPLACED THE SUBJECT COIL AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH NO CLINICAL CONSEQUENCES TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10428815 ↗
• MalfunctionAug 11, 2020Fracture; Fracture

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394409 ↗
• MalfunctionFeb 24, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A A-COM EMBOLIZATION WITH THE SUBJECT COIL, IT BECAME STUCK IN CATHETER. WHEN IT WAS REMOVED, THE COIL WAS FOUND PREMATURELY DETACHED. THE PATIENTS MEDICAL CONDITION WAS GOOD. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745346 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE FOR COIL EMBOLIZATION LOCATED IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, WHEN ADVANCING THE SUBJECT COIL OUT OF MICROCATHETER, THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED THE SUBJECT COIL WAS BIGGER THAN IT SHOULD BE, AND IT PERFORATED THE ANEURYSM. THUS, THE OPERATOR IMMEDIATELY DETACHED THE SUBJECT COIL INSIDE THE PATIENT¿S ANEURYSM AND USED OTHER BRAND COILS TO FINISH THE EMBOLIZATION COMPLETELY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT AND THE PATIENT¿S CURRENT CONDITION IS GOOD.

  Patient problems: Aneurysm; Rupture

  MAUDE report 8570275 ↗
• InjuryNov 1, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A DEPLOYED COIL STRETCHED AND PROTRUDED INTO THE INTERNAL CAROTID (IC) WHEN THE MICROCATHETER WAS REMOVED AND A STENT WAS DEPLOYED TO FIX THE PROTRUSION. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8031310 ↗
• MalfunctionOct 2, 2018Unintended Movement; Unintended Movement

  A (B)(6) FEMALE (HYPERTENSION, PREVIOUS SMOKER) UNDERWENT STENT ASSISTED COIL EMBOLIZATION OF ANEURYSM IN RIGHT MIDDLE CEREBRAL ARTERY (MCA) (B)(6) 2017. WHEN THE PATIENT WAS SEEN FOR FOLLOW-UP APPROXIMATELY ONE YEAR LATER (B)(6) 2018, IT WAS REPORTED THE COIL MIGRATED THROUGH THE STENT STRUTS AND WAS PROTRUDING SLIGHTLY INTO THE ARTERY, AS OBSERVED ON DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT; THE EVENT WAS NOTED TO RESOLVE WITHOUT SEQUELAE THE SAME DAY ((B)(6) 2018). ADDITIONAL INFORMATION FROM THE PHYSICIAN INDICATED THE STENT WAS USED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7928892 ↗
• MalfunctionOct 5, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE COIL DETACHED PREMATURELY DURING THE PROCEDURE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6918907 ↗
• MalfunctionOct 6, 2016Break; Break

  IT WAS REPORTED THAT BEFORE USE, THE MAIN COIL (SUBJECT DEVICE) BROKE INSIDE THE MICROCATHETER HUB. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6004875 ↗
• InjuryMay 6, 2016Break; Break

  IT WAS REPORTED THAT DURING REPOSITIONING OF A COIL FOR EMBOLIZATION OF AN ANEURYSM OF THE POSTERIOR COMMUNICATING ARTERY, THE COIL STRETCHED AND BROKE IN THE PATIENT. THE BROKEN PART OF THE COIL WAS REMOVED USING A SNARE RETRIEVAL DEVICE WITHOUT PATIENT COMPLICATION DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5638016 ↗