TARGET M0035422030Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540675835), received between Mar 29, 2017 and Nov 17, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING EMERGENCY CEREBRAL EMBOLIZATION, SUBJECT COIL DETACHED ON ITS OWN IN THE MICROCATHETER BASE DURING USE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577972 ↗
• MalfunctionOct 17, 2025Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) WAS RETURNED DETACHED. 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 23324127 ↗
• MalfunctionNov 10, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED DURING THE PROCEDURE WHEN THE SUBJECT COIL TIP WAS FULLY INSERTED, THE TWO RO MARKERS WERE MISALIGNED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH REPLACING THE COIL AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12791674 ↗
• MalfunctionJul 1, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT SUBJECT COIL WAS USED FOR THE DISSOCIATION OF THE ACA (ANTERIOR CEREBRAL ARTERY) DISTAL BEFORE TREATING THE A-COM (ANTERIOR COMMUNICATING ARTERY) ANEURYSM. AFTER PLACING SUBJECT COIL TO THE TARGETED LESION ACA (ANTERIOR CEREBRAL ARTERY) DISTAL AND WHEN ATTEMPT WAS MADE TO DETACH THE SUBJECT COIL, DETACHMENT SYSTEM COULD NOT WORK AND SUBJECT COIL COULD NOT BE DETACHED. SO PHYSICIAN WITHDREW THE COIL DELIVERY WIRE AND PROCEEDED FOR A-COM (ANTERIOR COMMUNICATING ARTERY) COIL EMBOLIZATION WITH NEW DEVICE. IT WAS ASSUMED THAT THE SUBJECT COIL WAS REMOVED WITHOUT ANY PROBLEM DURING THE CASE SINCE THE CONDITION WAS NOT CONFIRMED. WHEN OTHER COIL WAS PLACED IN THE ANEURYSM AND GOT DETACHED BY USING DETACHMENT SYSTEM, IT COULD NOT BE FILLING NEATLY IN THE ANEURYSM. SO PHYSICIAN THOUGHT THAT OTHER COIL WAS STRETCHED OR PREMATURELY DETACHED. HE REMOVED IT FROM THE ANEURYSM AND INSPECTED IT. OTHER COIL HAD KEPT THE PROTOTYPE QUITE A BIT, SO IT WAS THOUGHT THAT SOME FOREIGN SUBSTANCE WAS MIXED IN THE INTRODUCER SHEATH OF THE COIL AND THAT IT WAS LEFT BEHIND IN THE ANEURYSM. BY CAREFULLY EXAMINING THE IMAGES AND VIDEOS OF THIS CASE, IT WAS CONFIRMED THAT THE ENTIRE SUBJECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104618 ↗
• MalfunctionJun 8, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL DELIVERY WIRE WAS NOTED TO BE 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 11963104 ↗
• MalfunctionJul 1, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN COULDN'T SEE THE COIL (SUBJECT DEVICE) UNDER FLUOROSCOPY. THE PHYSICIAN REMOVED THE CATHETER AND FLUSHED IT AND FOUND THAT THE SUBJECT COIL HAD PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10222225 ↗
• InjuryDec 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A STENT ASSISTED-COILING PROCEDURE OF A SMALL, UN-RUPTURED, RIGHT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC ANEURYSM IN A RELATIVELY DYSPLASTIC VESSEL. THE STENT WAS SUCCESSFULLY DEPLOYED ACROSS THE ANEURYSM NECK USING JAILED TECHNIQUE. THE PHYSICIAN ATTEMPTED TO DEPLOY A FIRST COIL 2MM X 3CM (SUBJECT DEVICE), BUT THE COIL APPEARED TO BE TOO BIG AND LONG FOR THE ANEURYSM, AS THE COIL KEPT HERNIATING DOWNWARD INTO THE PARENT VESSEL. PRIOR TO DETACHING THE COIL, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT¿S BODY. THE PHYSICIAN SWITCHED TO A 1.5MM X 2CM COIL. UNFORTUNATELY, THE SAME ISSUE HAPPENED WITH THIS COIL AS IT CONTINUED TO HERNIATE DOWN INTO THE PARENT VESSEL. PRIOR TO DETACHING THE COIL, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT¿S BODY. THE PHYSICIAN SWITCHED TO A 1MM X 1CM COIL. THIS 1MM X 1CM COIL SUCCESSFULLY DEPLOYED INTO THE ANEURYSM DOME AND WAS DETACHED. UPON INSPECTING THE COIL MASS, AS THE PHYSICIAN NOTICED THAT THERE WAS STILL OPEN SPACE IN THE MIDDLE OF THE ANEURYSM, THE PHYSICIAN DECIDED TO DEPLOY OF A SECOND 1MM X 1CM COIL INTO THE ANEURYSM DOME. UNFORTUNATELY, THIS SECOND 1MM X 1CM COIL MECHANICALLY PUSH

  Patient problems: High Blood Pressure/ Hypertension; Intracranial Hemorrhage

  MAUDE report 9434930 ↗
• MalfunctionNov 26, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE BALLOON ASSISTED COILING PROCEDURE, THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED FROM THE DELIVERY WIRE. THE COIL WAS REMOVED FROM THE PATIENT ANATOMY WITHIN THE MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378539 ↗
• MalfunctionMar 29, 2017Break; Break

  BASED ON THE INVESTIGATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE COIL DELIVERY WIRE WAS BROKEN/FRACTURED. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6444212 ↗