TARGET M0035452060Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613252600381), received between May 25, 2016 and Apr 16, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT MAIN COIL WAS NOTED TO BE DETACHED/SEPARATED FROM THE DELIVERY WIRE. 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 24901771 ↗
• MalfunctionNov 25, 2025Premature Separation; Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT MAIN COIL WAS NOTED TO BE DETACHED/SEPARATED FROM THE SUBJECT COIL DELIVERY WIRE. 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 23652423 ↗
• MalfunctionDec 21, 2023Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) WAS BROKEN/FRACTURED NEAR THE DETACHMENT ZONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374325 ↗
• MalfunctionMar 21, 2022Migration; Migration

  IT WAS REPORTED THAT AFTER INSERTING THE SUBJECT COIL INTO THE MICROCATHETER AND DETACHING IT, THE DELIVERY WIRE WAS PUSHED OUT A LITTLE INSIDE THE MICROCATHETER AND THEN REMOVED. WHEN AN ATTEMPT WAS MADE TO RETRIEVE THE MICROCATHETER, THE SUBJECT DETACHED COIL WAS ATTACHED TO THE TIP OF THE MICROCATHETER, THUS THIS SUBJECT DETACHED COIL WAS RETRIEVED WITH THE ENTIRE MICROCATHETER TO THE OUTSIDE OF THE BODY. THE ENTIRE SUBJECT COIL WAS SAFELY REMOVED WITH THE MICROCATHETER, AND THE PROCEDURE WAS COMPLETED AS IT WAS (NO ADDITIONAL COIL TO PLACE). THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839353 ↗
• MalfunctionApr 6, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DEPLOYED WHILE IT HAD ADVANCED JUST BEYOND THE MICROCATHETER HUB. THE PHYSICIAN REPLACED THE SUBJECT DEVICE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625614 ↗
• MalfunctionFeb 24, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR ACHIEVING HEMOSTASIS IN TRAUMA PATIENT, RESISTANCE WAS ENCOUNTERED WHEN THE COIL WAS ADVANCED INTO THE INTRODUCER SHEATH AND WHEN THE SUBJECT COIL WAS INSERTED INTO THE MICROCATHETER. WHEN THE SUBJECT COIL WAS TRIED TO BE PULL BACK, IT WAS ALREADY EARLY DETACHED. THE COIL WAS COLLECTED AND THE OPERATOR WAS ABLE TO REMOVE ALL PART OF THE DETACHED COIL FROM THE PATIENT ANATOMY. AFTER RETRIEVAL OF EARLY DETACHED SUBJECT COIL, AND REPLACING IT WITH A NEW DEVICE , ONE MORE COIL IS ADDED TO TARGET SITE 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 11376287 ↗
• MalfunctionOct 16, 2020Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10688565 ↗
• MalfunctionJun 30, 2020Difficult to Advance; Difficult to Advance

  THE COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE DELIVERY WIRE OF THE SUBJECT COIL WAS KINKED AND SUBSEQUENTLY BROKEN DURING THE PROCEDURE. THE SUBJECT COIL WAS ALSO FOUND TO BE KINKED, BENT AND STRETCHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10214726 ↗
• MalfunctionJan 3, 2019Break; Break

  BASED ON THE INVESTIGATION OF THE RETURNED PRODUCT, THE COIL (SUBJECT DEVICE) WAS FOUND TO BE BROKEN/FRACTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8214402 ↗
• MalfunctionNov 13, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL WAS PREMATURELY DETACHED IN THE MICROCATHETER HUB, OUTSIDE THE PATIENT¿S BODY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8065410 ↗
• 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 7928877 ↗
• InjurySep 7, 2018Material Protrusion/Extrusion; Premature Separation; Material Protrusion/Extrusion; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN PULLED BACK THE SUBJECT COIL AND THE MAIN COIL PREMATURELY DETACHED. HALF OF THE COIL REMAINED IN THE ANEURYSM WHILE THE OTHER HALF PROTRUDED, MAKING A TAIL ON THE PATIENT¿S VESSEL. THE PHYSICIAN DEPLOYED A STENT TO PREVENT THE PROTRUDED COIL FROM BLOCKING THE PATIENT¿S VESSEL. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7858115 ↗
• MalfunctionDec 6, 2016Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6148942 ↗
• MalfunctionJun 15, 2016Break; Break

  THE ANALYSIS OF THE RETURNED COIL REVEALED THAT THE DELIVERY WIRE AT THE DETACHMENT ZONE WAS FOUND TO BE BROKEN. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5727974 ↗
• MalfunctionMay 25, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE ADVANCEMENT OF THE COIL (SUBJECT DEVICE) INTO THE MICROCATHETER, THE COIL PREMATURELY DETACHED IN THE MICROCATHETER. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5680210 ↗