TARGET M0035474100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613252192756), received between Feb 7, 2017 and Jul 3, 2024 — classified as 1 death, 2 injuries, 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL DELIVERY WIRE PROXIMAL END WAS BROKEN/FRACTURED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667692 ↗
• MalfunctionOct 11, 2023Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED/SEPARATED 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 17910091 ↗
• MalfunctionDec 20, 2022No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THAT DURING PCOMA ANEURYSM PROCEDURE, RESISTANCE ENCOUNTERED WHEN ADVANCING AND RETRACTING THE SUBJECT COIL. THE SUBJECT COIL COULD NOT BE SEEN UNDER DSA (DIGITAL SUBTRACTION ANGIOGRAPHY). WHEN THE OPERATOR WITHDREW THE SUBJECT COIL IT WAS FOUND STRETCHED. 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 16019866 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TREATMENT OF ANTERIOR CEREBRAL ARTERY (ACA) ANEURYSM, IT WAS REPORTED THAT THE ANEURYSM RUPTURED AFTER THE DEPLOYMENT OF THE 5TH COIL (SUBJECT DEVICE). A COMPLIANT BALLOON WAS PLACED AND INFLATED IN THE RIGHT A1 SEGMENT AND HEPARIN WAS REVERSED TO TREAT THE RUPTURE. THE 6TH COIL WAS DEPLOYED AND DETACHED WITHOUT ISSUE. WHEN THE 7TH COIL WAS DEPLOYED, AN APPROXIMATELY 1CM OF THE COIL TAIL MIGRATED INTO THE LEFT A2 SEGMENT. AT THAT TIME, NO SUITABLE RETRIEVAL DEVICES WERE AVAILABLE, SO THE DECISION WAS MADE TO DEPLOY A STENT TO SECURE THE SUBJECT COIL TAIL. THROMBUS FORMATION WAS NOTED WITHIN THE STENT AND THE RIGHT A2 SEGMENT. THE PATIENT WAS ADMINISTERED WITH IV ASPIRIN AND REOPRO WITH GOOD RESULT. THE PATIENT WAS KEPT IN ICU OVERNIGHT AND IS BEING SLOWLY WOKEN THROUGHOUT THE DAY TODAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aneurysm; Rupture

  MAUDE report 9175421 ↗
• MalfunctionOct 1, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE COIL COULD NOT BE DETACHED AFTER THREE ATTEMPTS. SO THE PHYSICIAN DECIDED TO REMOVE COIL. HOWEVER, THE COIL WAS DETACHED PREMATURELY INSIDE THE MICROCATHETER HUB DURING REMOVAL. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9142919 ↗
• MalfunctionJul 23, 2019Break; Break

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE SUBJECT COIL'S DELIVERY WIRE FRACTURED WHEN DELIVERING TO THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND FINISHED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8819783 ↗
• MalfunctionAug 14, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE WHILE ADVANCING THE COIL WITHIN THE MICROCATHETER, THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED. THE COIL WAS REMOVED WITH THE MICROCATHETER AND THE PATIENT WAS RE-CANNULATED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7782115 ↗
• DeathJul 30, 2018Break; Migration; Break; Migration

  DURING A COIL PROCEDURE OF A RUPTURED 7MM POSTERIOR COMMUNICATING ARTERY (PCOMM) ANEURYSM, THE PHYSICIAN REPORTED THAT WHEN PLACING THE THIRD COIL INTO THE ANEURYSM, THE COIL PUSHED THE MICROCATHETER OUT OF THE ANEURYSM. WHEN THE PHYSICIAN WAS TRYING TO PULL THE COIL BACK AND REPOSITION THE DELIVERY WIRE, THE COIL SNAPPED PROXIMALLY. THE PHYSICIAN THEN TRIED TO PULL BACK THE COIL WITH THE MICROCATHETER; HOWEVER, THE COIL MIGRATED ACROSS THE PCOMM INTO THE INTERNAL CAROTID ARTERY (ICA) AND OCCLUDED THE MIDDLE CEREBRAL ARTERY-M2 SEGMENT FOR MORE THAN 10 MINUTES. A SNARE DEVICE WAS USED TO RETRIEVE THE COIL OUT OF THE PATIENT¿S BODY. HALF DOSE OF ABCIXIMAB (REOPRO) MEDICATION WAS GIVEN TO THE PATIENT AND THE ANEURYSM WAS COILED FURTHER AND STENT WAS PLACED IN THE PARENT VESSEL. THE NEXT MORNING POST PROCEDURE, THE PATIENT RE-BLED FROM THE SAME ANEURYSM AND PASSED AWAY. THE PHYSICIAN INDICATED THAT THE INITIAL REASON FOR THE PATIENT DEATH WAS DUE TO THE COIL BREAKING BUT THE FINAL CAUSE OF DEATH WAS DUE TO THE ANTI-PLATELET (REOPRO) MEDICATION GIVEN TO THE PATIENT TO STOP STROKE BECAUSE THE COIL HAD MIGRATED.

  Patient problems: Death; Hemorrhage, Cerebral; Stroke/CVA

  MAUDE report 7733125 ↗
• InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT. POST-PROCEDURE THE PATIENT WAS NEUROLOGICALLY ASSESSED AS HAVING A MRS (MODIFIED RANKING SCALE) OF 0. 16 DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED HEADACHE THAT LASTED 9 DAYS. MEDICATIONS PROCHLORPERAZINE 10 MG IV AND DIPHENHYDRAMINE 12.5 MG WERE ADMINISTERED ON THE 19 DAYS POST-PROCEDURE AS OUT-PATIENT IN EMERGENCY DEPARTMENT (ED) IN ORDER TO TREAT THE HEADACHE. PRESCRIPTIONS FOR COMPAZINE 10 MG PO AND BENADRYL 25 MG PO WERE GIVEN TO THE PATIENT WHEN DISCHARGED FROM ED. THE HEADACHE WAS RESOLVED WITHOUT ANY RESIDUAL EFFECTS. ACCORDING TO THE PHYSICIAN, THE HEADACHE WAS PROBABLY RELATED TO THE PROCEDURE AND TO THE STENT. IT WAS UNKNOWN IF THE HEADACHE WAS RELATED TO THE IMPLANTED COILS. THE PATIENT WAS ASSESSED HAVING A MRS OF 0 AT 2-MONTH POST-INDEX PROCEDURE.

  Patient problems: Headache; Visual Disturbances

  MAUDE report 6853524 ↗
• MalfunctionJul 28, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN THE COIL WAS ADVANCED IN THE MICROCATHETER, IT DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE MICROCATHETER WAS REMOVED ALONG WITH THE COIL FROM THE PATIENT. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6750066 ↗
• MalfunctionFeb 7, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS PREMATURELY SEPARATED FROM THE DELIVERY WIRE AT THE DETACHMENT ZONE INSIDE THE ROTATING HEMOSTATIC VALVE (RHV) WHILE BEING RETRACTED AND RE-SHEATHED DUE TO THE RESISTANCE ENCOUNTERED DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER SHAFT. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6309568 ↗