Target M0035434150Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540676122), received between Jun 16, 2016 and Nov 4, 2025 — classified as 5 injuries, 2 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT SUBJECT COIL DELIVERY WIRE WAS BROKEN PROXIMALLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466776 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN DECIDED TO RETRIEVE THE COIL (SUBJECT DEVICE) BECAUSE THE COIL WAS FELT LONGER. HOWEVER, RESISTANCE WAS FELT WHEN THE PHYSICIAN TRIED TO RETRIEVE THE COIL AND ANOTHER COIL WHICH WAS IMPLANTED IN THE ANEURYSM PREVIOUSLY WAS RETRIEVED ALONG WITH THE SUBJECT DEVICE. EVENTUALLY BOTH COILS WERE REMOVED BY USING SNARE AND THE SUBJECT DEVICE WAS FOUND STRETCHED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8800757 ↗
• MalfunctionJun 10, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING NEURO EMBOLIZATION PROCEDURE, THE FRICTION WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT COIL IN THE MICROCATHETER AND IT WAS HARD TO ADVANCE THE SUBJECT COIL; THEREFORE, THE SUBJECT COIL WAS WITHDRAWN, AND KINK WAS OBSERVED. AFTER BEING RETRIEVED BACK INTO THE MICROCATHETER, THE SUBJECT COIL WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE SAME MICROCATHETER AND A DIFFERENT COIL WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8684874 ↗
• InjuryJul 24, 2018Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT DURING STENT-ASSISTED COIL EMBOLIZATION OF A RUPTURED ANEURYSM LOCATED IN THE LEFT POSTERIOR COMMUNICATING ARTERY (PCOMM), MIDWAY THROUGH DEPLOYMENT OF THE SECOND COIL (SUBJECT DEVICE), THE DELIVERY WIRE PREMATURELY DETACHED FROM THE COIL AND THE COIL MIGRATED. ANGIOGRAMS SHOWED THROMBUS PROPAGATION IN THE LEFT PCOMM AND BLOOD FLOW STASIS IN THE DISTAL BRANCHES OF THE LEFT PCOMM. ANTIPLATELET DRUG (TIROFIBAN) WAS ADMINISTERED. A STENT WAS PARTIALLY DEPLOYED IN THE TERMINAL ICA TO COMPLETE THE COILING AND THEN THE STENT WAS FULLY DEPLOYED TO JAIL THE MIGRATED COIL. THE DISTAL PART OF THE COIL HOWEVER STILL MIGRATED OUTSIDE THE DEPLOYED STENT INTO THE TO THE INTERNAL CAROTID ARTERY (ICA) BIFURCATION. MOVEMENT OF THE COIL WITH BLOOD PULSATION WAS NOTED. ANOTHER STENT WAS DEPLOYED TO SECURE AND JAIL THE STILL DISTALLY MIGRATED COIL. THROMBUS IN THE LEFT PCOMM WAS RESOLVED AND BLOOD FLOW WAS RESTORED.

  Patient problems: Device Embedded In Tissue or Plaque; Thrombus

  MAUDE report 7715266 ↗
• InjuryJul 16, 2018Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE FOR ANEURYSM LOCATED AT THE POSTERIOR COMMUNICATING ARTERY, THE SUBJECT COIL DEPLOYED PREMATURELY. THE ANGIOGRAMS SEVERAL MINUTE LATER INDICATED THROMBUS PROPAGATION IN THE LEFT POSTERIOR COMMUNICATING ARTERY AND FLOW STASIS IN THE DISTAL BRANCHES OF THE LEFT COMMUNICATING ARTERY. ANTIPLATELET MEDICATION (TIROFIBAN) WAS GIVEN. STENTING OF THE ANEURYSM WAS UNDERTAKEN TO ASSIST THE COMPLETION OF THE COIL EMBOLIZATION AND TO JAIL THE MIGRATED COIL AGAINST THE VESSEL WALL. HOWEVER, THE DISTAL PART OF THE SUBJECT COIL WAS STILL MIGRATED OUTSIDE THE DEPLOYED STENT INTO THE INTERNAL CAROTID ARTERY (ICA) BIFURCATION. THE ANGIOGRAMS SHOWED MOVEMENT OF THE COIL WITH BLOOD PULSATION; THEREFORE, ANOTHER STENT WAS DEPLOYED TO SECURE AND JAIL THE DISTALLY MIGRATED COIL. THE THROMBUS IN THE LEFT POST COMMUNICATING ARTERY WAS RESOLVED AND BLOOD FLOW WAS RESTORED.

  Patient problems: Thrombus

  MAUDE report 7690720 ↗
• InjuryOct 5, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE COIL HAD BEEN REPOSITIONED SEVERAL TIMES WHEN IT MECHANICALLY DETACHED. THE PHYSICIAN REMOVED THE COIL WITH A GOOSENECK SNARE DEVICE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6001574 ↗
• InjuryJun 16, 2016Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING STENT ASSISTED COILING OF ANEURYSM, THE SUBJECT MAIN COIL PROXIMAL SECTION STRETCHED DURING IMPLANTATION, BROKE AND PROTRUDED FROM THE ANEURYSM INTO THE PARENT VESSEL. THROMBOSIS ON THE STRETCHED COIL OCCURRED. PLATELET AGGREGATION INHIBITOR MEDICATION WAS ADMINISTERED. THE PATIENT ADVERSE CONSEQUENCE WAS A STROKE OF UNKNOWN SEVERITY. ACCORDING TO THE PHYSICIAN, IT IS DIFFICULT TO KNOW IF THE COIL GOT TANGLED IN COIL MASS, WRAPPED AROUND A STRUT OF A THE STENT, OR SOME OTHER CAUSE.

  Patient problems: Stroke/CVA; Thrombosis

  MAUDE report 5729080 ↗