TARGET M0035421540Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04546540697998), received between May 25, 2018 and Jun 22, 2026 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (14 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Premature Separation

  It was reported that the coil (subject device) was used in the medical procedure. However, the subject coil encountered resistance while advancing through the microcatheter and got detached prematurely. The procedure was reported to be completed successfully. No clinical consequences were reported to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25587935 ↗
• MalfunctionJun 22, 2026Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT COIL ENCOUNTERED RESISTANCE WHILE ADVANCING THROUGH THE MICROCATHETER AND GOT DETACHED PREMATURELY. THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25587901 ↗
• MalfunctionMay 5, 2026Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE COIL DELIVERY WIRE WAS KINKED/BENT AND WAS BROKEN/FRACTURED DURING USE. THE SUBJECT DEVICE WAS REPORTED TO BE REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086831 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT MIDDLE MENINGEAL ARTERY (MMA), PATIENT WINCHED AND STATED THEY EXPERIENCED PAIN UPON DEPLOYMENT OF THE SUBJECT COIL. THIS WAS THE 3RD COIL AND THE PATIENT WAS UNDER CONSCIOUS SEDATION. AFTER THAT, THE 4TH COIL WAS DEPLOYED SUCCESSFULLY WITHOUT PAIN BY KEEPING SOME OF THE MARKER SHEATHED BY THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Pain

  MAUDE report 23442230 ↗
• MalfunctionJun 13, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT WHEN THE RO MARKER (RADIOPACITY MARKER) ON THE PUSHER WIRE OF THE SUBJECT COIL WAS AT THE APPROPRIATE POINT LINED UP WITH THE PROXIMAL MICROCATHETER MARKER, IT APPEARED EXCESS SUBJECT COIL DELIVERY WIRE WAS OUTSIDE OF THE MICROCATHETER TIP. THE SUBJECT DEVICE WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL COILS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204064 ↗
• MalfunctionMay 22, 2024Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL (SUBJECT DEVICE) WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373540 ↗
• MalfunctionDec 21, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE COIL INTO THE MICROCATHETER HUB AND WITHIN THE MICROCATHETER SHAFT. HE EXPERIENCED THE SAME FRICTION WITH OTHER TWO COILS AS WELL. WHILE ADVANCING THE SUBJECT COIL , PHYSICIAN APPLIED EXCESSIVE FORCE AND THE SUBJECT COIL DETACHED PREMATURELY WITHIN THE MICROCATHETER. THE SUBJECT COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371384 ↗
• MalfunctionDec 13, 2023Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) WAS FOUND TO BE PREMATURELY DETACHED DURING USE. 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 18322760 ↗
• MalfunctionNov 14, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE OF VENOUS SINUS EMBOLI OF DURAL-AVF, THE COIL (SUBJECT DEVICE) WAS ADVANCED INTO THE MICROCATHETER, BUT THERE WAS STRONG RESISTANCE ABOUT 10 CM BEFORE THE TIP OF THE CATHETER, SO IT WAS RETRIEVED. WHILE RETRIEVING THE COIL (SUBJECT DEVICE) , IT GOT PREMATURELY DETACHED AT THE RHV(ROTATING HEMOSTASIS VALVE). THE DETACHED COIL (SUBJECT DEVICE) WAS SAFELY REMOVED FROM THE PATIENT¿S ANATOMY BY REMOVING THE RHV. 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 15795255 ↗
• MalfunctionNov 4, 2022Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND WAS EXAMINED. DURING DEVICE INVESTIGATION AND ANALYSIS, IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) MAIN COIL WAS FOUND TO BE BROKEN/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 15738882 ↗
• MalfunctionOct 31, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE ANTERIOR COMMUNICATING ANEURYSM EMBOLIZATION PROCEDURE, THE PHYSICIAN FILLED FOUR COILS INTO THE ANEURYSM. HE FELT RESISTANCE, WHILE INSERTING THE FIFTH COIL INTO THE MICROCATHETER HUB. THE SYSTEM WAS CLOTTED AND PHYSICIAN HAD TO PERFORM THE HEPARIN PROTOCOL. HE REPLACED THE COIL WITH THE SUBJECT COIL. WHILE ADVANCING THE SUBJECT COIL WITHIN THE MICROCATHETER SHAFT RESISTANCE WAS ENCOUNTERED AND THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. 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 15697805 ↗
• MalfunctionOct 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, ONE OF THE SEVEN COILS BROKE AND GOT STUCK WITHIN THE LUMEN OF THE MICROCATHETER WHICH DID NOT ALLOW OTHER COILS TO BE DEPLOYED. THE DETACHMENT SYSTEM WAS ALSO REPORTED TO HAVE STOPPED DURING THE CASE. THE BROKEN SUBJECT COIL ALONG WITH THE MICROCATHETER WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581088 ↗
• MalfunctionSep 16, 2022Break; Activation Problem

  ONE COIL FAILED DURING DEPLOYMENT AND BROKE OFF IN CATHETER, WHICH RESULTED IN THE OTHER COILS NOT BEING ABLE TO DEPLOY, AND THE DETACHER STOPPED WORKING DURING THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 15437488 ↗
• MalfunctionJun 7, 2022Premature Separation; Premature Separation

  IT IS REPORTED THAT THE COIL (SUBJECT DEVICE) DETACHED IN THE MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628543 ↗
• MalfunctionMar 30, 2022Fracture; Fracture

  IT WAS INITIALLY REPORTED THAT THE SUBJECT COIL COULD NOT BE ADVANCED THROUGH A MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THE EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THE SUBJECT COIL DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT COIL DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13957358 ↗
• MalfunctionDec 2, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THE COIL DELIVERY WIRE (SUBJECT DEVICE) BROKEN/FRACTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12921886 ↗
• MalfunctionJul 27, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING ONE BA ANEURYSM CASE, WHEN USING THE SUBJECT COIL TO FINISH, THE COIL (SUBJECT DEVICE) COULD NOT BE PUSHED AT DISTAL OF MICROCATHETER EVEN AFTER SEVERAL TRIES. THE OPERATOR REPLACED THE SUBJECT COIL WITH ANOTHER BRAND AND CONTINUED THE PROCEDURE SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE RETURNED DEVICE FOUND THE COIL DELIVERY WIRE BROKEN/FRACTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229299 ↗
• MalfunctionJun 21, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS NOTED TO BE STRETCHED AND PREMATURELY DETACHED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035480 ↗
• MalfunctionApr 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE MICROCATHETER WAS USED WITH THE SUBJECT COIL EMBOLIZATION. WHEN DELIVERING THE SUBJECT COIL IN THE MICROCATHETER, THE RESISTANCE ENCOUNTERED IN THE MICROCATHETER AND IT WAS STUCK IN THE MICROCATHETER. DURING WITHDRAWAL ,THE SUBJECT COIL WAS FRACTURED IN MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A DIFFERENT NEW COIL AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11666984 ↗
• MalfunctionFeb 16, 2021Migration; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE SUBJECT COIL WAS USED, THE PHYSICIAN WAS ABLE TO PACK AND DETACH THE SUBJECT COIL AT TARGET LOCATION. HOWEVER UPON ATTEMPTING TO REMOVE THE CATHETER, THE PROXIMAL TIP OF THE SUBJECT COIL WAS STUCK NEAR THE CATHETER TIP AFTER ITS DETACHMENT. THE PHYSICIAN USED ALREADY EXISTING GUIDEWIRE TO REMOVE THE SUBJECT COIL FROM THE CATHETER TIP BUT COULDN'T GET IT OUT OF THE CATHETER. AFTER MULTIPLE REMOVAL ATTEMPTS THE PHYSICIAN WAS SUCCESSFUL IN SEPARATING THE SUBJECT COIL FROM THE CATHETER TIP. PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334982 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) -2020, THE PATIENT EXPERIENCED DECIMATING HEADACHES, SHE REPORTED VOMITING THREE TIMES ON AND WAS TRANSFERRED TO THE (B)(6) GENERAL HOSPITAL FROM THE (B)(6) MEDICAL CENTER EAST. THE PATIENT WAS ADMITTED TO THE (B)(6) MEDICAL CENTER EAST, INITIALLY STILL ALERT AND RESPONSIVE (HH3) AND NEURORADIOLOGICAL DIAGNOSTICS WERE PERFORMED BY CCT AND CTA. THIS REVEALED AN EXTENDED INTERHEMISPHERIC SAH AT RESULTING FROM AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. GIVEN THE PATIENT¿S CLINICAL DETERIORATION IN TERMS OF A DETERIORATING CONSCIOUSNESS AND HYDROCEPHALUS, SHE RECEIVED AN EVD AND WAS SUBSEQUENTLY TRANSFERRED TO THE ENDOVASCULAR SURGERY ROOM IN VIENNA GENERAL HOSPITAL. SHE WAS TAKEN DIRECTLY TO THE ANGIOGRAPHY SUITE BY AMBULANCE TRANSPORT. DURING THE INTRAVASCULAR COILING PROCEDURE, PATIENT IN THE SUPINE POSITION, INTUBATION ANESTHESIA, TRANSFEMORAL APPROACH. 6F LOCK. A 6F CATHETER IS ADVANCED AND PLACED IN THE RIGHT COMMON CAROTID ARTERY. ANGIOGRAPHY TAKEN IN BOTH PLANES, MAGNIFIED AND NOT MAGNIFIED, SHOW THE FILLING OF THE RIGHT A2 VIA THE A1, BUT ONLY A PARTIAL ANEURYSM FILLING. THE CATHETER IN THE INTERNAL CAROTID ARTERY IS EXCHANGED ON THE LEFT. IT IS NOTED THAT THE ANEURY

  Patient problems: Thromboembolism

  MAUDE report 10709725 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT EXPERIENCED DECIMATING HEADACHES, SHE REPORTED VOMITING THREE TIMES ON AND WAS TRANSFERRED TO THE (B)(6) GENERAL HOSPITAL FROM (B)(6) MEDICAL CENTER EAST. THE PATIENT WAS ADMITTED TO THE SOCIAL MEDICAL CENTER EAST, INITIALLY STILL ALERT AND RESPONSIVE (HH3) AND NEURORADIOLOGICAL DIAGNOSTICS WERE PERFORMED BY CCT AND CTA. THIS REVEALED AN EXTENDED INTERHEMISPHERIC SAH AT RESULTING FROM AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. GIVEN THE PATIENT¿S CLINICAL DETERIORATION IN TERMS OF A DETERIORATING CONSCIOUSNESS AND HYDROCEPHALUS, SHE RECEIVED AN EVD AND WAS SUBSEQUENTLY TRANSFERRED TO THE ENDOVASCULAR SURGERY ROOM IN (B)(6) GENERAL HOSPITAL. SHE WAS TAKEN DIRECTLY TO THE ANGIOGRAPHY SUITE BY AMBULANCE TRANSPORT. DURING THE INTRAVASCULAR COILING PROCEDURE, PATIENT IN THE SUPINE POSITION, INTUBATION ANESTHESIA, TRANSFEMORAL APPROACH. 6F LOCK. A 6F CATHETER IS ADVANCED AND PLACED IN THE RIGHT COMMON CAROTID ARTERY. ANGIOGRAPHY TAKEN IN BOTH PLANES, MAGNIFIED AND NOT MAGNIFIED, SHOW THE FILLING OF THE RIGHT A2 VIA THE A1, BUT ONLY A PARTIAL ANEURYSM FILLING. THE CATHETER IN THE INTERNAL CAROTID ARTERY IS EXCHANGED ON THE LEFT. IT IS NOTED THAT THE ANEURYSM IS

  Patient problems: Thromboembolism

  MAUDE report 10709722 ↗
• MalfunctionSep 22, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL PREMATURELY DETACHED WHILE INSIDE A MICRO CATHETER. THE SUBJECT COIL WAS COMPLETELY REMOVED FROM THE PATIENT'S ANATOMY. THE PHYSICIAN REPLACED THE DEVICE WITH A SIMILAR ONE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10570891 ↗
• MalfunctionAug 5, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT MCA ANEURYSM. PHYSICIAN PLACED GUIDE CATHETER AND THEN USED GUIDEWIRE TO WORK WITH MICROCATHETER TO REACH THE LESION. DURING DELIVERY, THE SUBJECT COIL EXPERIENCED RESISTANCE AT THE TIP OF THE MICROCATHETER AND COULD NOT BE ADVANCED. THE PHYSICIAN REPLACED SUBJECT DEVICE WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE DEVICE REVEALED THAT THE SUBJECT MAIN COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE. THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED REPORTABLE AND EMDR WILL BE FILED WITH AN AWARENESS DATE OF 31-JUL-2020. THE PI WILL BE ASSESSED TO REFLECT THE DECISION CHANGE AND EMDR WILL BE FILED ACCORDINGLY.

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

  MAUDE report 10371291 ↗
• MalfunctionAug 5, 2020Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE MAIN COIL HAD PREMATURELY DETACHED DURING USE. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10369790 ↗