TARGET M0035424100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613252192336), received between Jun 27, 2016 and Feb 27, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A 3-MONTH FOLLOW UP, THE IMAGING REVEALED A FISHMOUTHING OF THE FLOW DIVERTER STENT AT THE DISTAL END. THE SUBJECT COIL WAS ALSO USED TO TREAT THE INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE PATIENT PREVIOUSLY EXPERIENCED WEAKNESS IN ONE LOWER LIMB, BUT THE CONDITION HAS IMPROVED AND IS NOW STABLE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 21484615 ↗
• MalfunctionMay 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A RIGHT VERTEBRAL ARTERY (VA) V5 DISSECTION ANEURYSM PROCEDURE THE OPERATOR USED A GUIDEWIRE TO BRING A MICROCATHETER INTO THE ANEURYSM. THE ANEURYSM WAS FRAMED WITH A COIL AND A STENT WAS DEPLOYED THROUGH THE MICROCATHETER. AFTER DELIVERING THREE COILS, THE PHYSICIAN DELIVERED THE SUBJECT COIL AS THE FOURTH COIL BUT IT WAS FOUND THAT THE TAIL OF THE DELIVERY WIRE WAS FRACTURED. 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 16944258 ↗
• MalfunctionNov 21, 2022Migration; Migration

  IT WAS REPORTED DURING ANEURYSM EMBOLIZATION CASE, USED A MICROCATHETER TO DELIVER THE SUBJECT COIL. THE DETACHMENT DEVICE SHOWED THE SUCCESSFUL DETACHMENT OF THE SUBJECT COIL. THE PHYSICIAN PREPARED TO WITHDRAW THE DELIVERY WIRE. HOWEVER, UNDER THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA), THE SUBJECT COIL WAS STILL CONNECTED WITH THE MICROCATHETER TIP. THE OPERATOR ATTEMPTED TO SEPARATE THE COIL FROM THE CATHETER BUT WAS UNSUCCESSFUL. FINALLY, HE DECIDED TO WITHDRAW THE MICROCATHETER AND THE SUBJECT COIL OUT OF PATIENT'S BODY TOGETHER AND FOUND THE SUBJECT COIL ATTACHED TO THE TIP OF THE 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 15832230 ↗
• MalfunctionApr 18, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE OF A RIGHT POSTERIOR COMMUNICATING INTRACRANIAL ANEURYSM, PHYSICIAN FAILED TO DETACH THE SUBJECT COIL. WHILE ADVANCEMENT THERE WAS A SPONTANEOUS DETACHMENT OF THE SUBJECT COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138271 ↗
• MalfunctionAug 25, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL (SUBJECT DEVICE) FAILED TO DETACH UPON MULTIPLE DETACHMENT ATTEMPTS. THE PHYSICIAN ATTEMPTED TO REMOVE AND REINSERT THE SUBJECT COIL AND FOUND THE DELIVERY WIRE TO BE KINKED. THE PHYSICIAN ATTEMPTED TO MAKE THE DELIVERY WIRE STRAIGHT BUT IT FRACTURED DURING THE ATTEMPT. 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; No Consequences Or Impact To Patient

  MAUDE report 10449065 ↗
• MalfunctionOct 27, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE COIL AND THE MICROCATHETER WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6062647 ↗
• MalfunctionJun 27, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER, IT DETACHED UNEXPECTEDLY. THE PHYSICIAN REMOVED THE MICROCATHETER ALONG WITH THE COIL STILL INSIDE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5752638 ↗