TARGET M0035442540Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613252600305), received between Jun 14, 2016 and Apr 1, 2026 — classified as 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THERE WAS RESISTANCE WHILE ADVANCING THE SUBJECT COIL FROM THE INTRODUCER SHEAH AND WHILE INSIDE THE MICROCATHETER SHAFT. THE PROXIMAL PART OF SUBJECT COIL DELIVERY WIRE WAS FOUND FRACTURED. 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 24756694 ↗
• MalfunctionJan 9, 2025Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT DEVICE DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. 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 21114131 ↗
• InjuryDec 18, 2024Fracture; Expulsion; Fracture; Expulsion

  IT WAS REPORTED THAT DURING AN ANTERIOR COMMUNICATING ARTERY (ACOM ARTERY) RUPTURED ANEURYSM CASE AFTER DEPLOYMENT OF THE SUBJECT COIL THE PHYSICIAN WAS WITHDRAWING THE MICROCATHETER AND THE PROXIMAL END PART OF THE COIL FRACTURED AND DEVIATED FROM THE ANEURYSM. A SNARE DEVICE WAS USED TO REMOVE THE COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20965055 ↗
• InjuryMar 29, 2024Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE WHEN THE SUBJECT COIL WAS ATTEMPTED TO DETACHED USING THE POWER SUPPLY SYSTEM, THE POWER SUPPLY SYSTEM GAVE THREE BEEPS TO SIGNAL DETACHMENT. WHEN THE PHYSICIAN PULLED BACK THE SUBJECT COIL, IT WAS STILL ATTACHED TO THE SUBJECT COIL DELIVERY WIRE. WHILE THE PHYSICIAN PULLED BACK THE SUBJECT COIL, THE SUBJECT COIL INTERACTED WITH AN ALREADY IMPLANTED COIL AND PULLED A LOOP FROM THE ALREADY IMPLANTED COIL OUT INTO THE PARENT ARTERY. WHEN THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE SUBJECT COIL HE DID NOT LIKE HOW IT LOOKED SO HE PULLED BACK ON THE SUBJECT COIL TO ADJUST. WHEN THE PHYSICIAN PULLED BACK THE SUBJECT COIL FOR THE SECOND TIME, THE SUBJECT COIL PREMATURELY DETACHED AND THE TAIL OF THE SUBJECT COIL WAS LEFT IN THE IN THE IN THE MICROCATHETER. AT THIS POINT THE PHYSICIAN USED THE SUBJECT COIL PUSHER WIRE TO PUSH THE TAIL OF THE SUBJECT COIL OUT OF THE MICROCATHETER. THROUGH THIS WHOLE PROCESS TWO COIL LOOPS WERE LEFT IN EACH A2 ARTERY. THE PROCEDURE WAS ABORTED AND PATIENT WAS PUT ON DUAL ANTIPLATELET THERAPY OVERNIGHT. THE NEXT DAY STENTS WERE USED TO TACK DOWN THE TWO COIL LOOPS LEFT IN EACH A2 ARTERY AND THE ISSUE WAS RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005432 ↗
• MalfunctionJun 10, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL ENCOUNTERED RESISTANCE WHILE ADVANCING OUT OF THE INTRODUCER SHEATH. ON FURTHER ADVANCING THE SUBJECT COIL THE PHYSICIAN FOUND THAT THE SUBJECT COIL WAS PREMATURELY DETACHED AT THE PROXIMAL SIDE 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 14653759 ↗
• MalfunctionDec 21, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE THE COIL (SUBJECT DEVICE) REPEATEDLY REPOSITIONED TO STABLE IN THE ANEURYSM AT IC-OP; HOWEVER, IT COULD NOT BE PLACED. THE COIL (SUBJECT DEVICE) WAS RETRIEVED AND FOUND STRETCHED AT PROXIMAL. WHEN CHECKED THE HUB OF THE MICROCATHETER THE REMAINING COIL (SUBJECT DEVICE) WAS FOUND. 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 13057578 ↗
• MalfunctionMar 16, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN USED SUBJECT COIL AND MICROCATHETER. PHYSICIAN NOTED THAT THE SUBJECT COIL COULD NOT BE ADVANCED DISTALLY WITHIN MICROCATHETER DUE TO THE ACUTE ANGLE OF THE ICA (INTERNAL CAROTID ARTERY) TO A1. PHYSICIAN STATED THAT THE COIL WAS DETACHED EARLY WITHIN THE MICROCATHETER DISTAL PART. THE MICROCATHETER AND SUBJECT COIL WERE THEN REMOVED TOGETHER AND WERE REPLACED WITH SIMILAR DEVICES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WERE NOTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499246 ↗
• InjuryDec 3, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE RESISTANCE FELT WHILE DELIVERING AND ADVANCEMENT OF THE COIL (SUBJECT DEVICE) INTO THE MICROCATHETER. SO DELIVERY WIRE (DW) WAS PULLED THE SURGEON JUDGED THE COIL WAS STRETCHED AS THERE WAS NO RESISTANCE. SO, THE COIL WAS REMOVED USING SNARE ALONG WITH THE MICROCATHETER. WHEN THE COIL WAS CHECKED OUTSIDE THE BODY, IT WAS NOT STRETCHED BUT THE COIL AND THE DELIVERY WIRE WERE SEPARATED. IT WAS CONSIDERED PREMATURELY DETACHMENT OF THE COIL. 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 10939500 ↗
• InjuryAug 27, 2019Migration; Migration

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE PART OF THE COIL (SUBJECT DEVICE) WAS STUCK IN THE TIP OF THE MICROCATHETER AFTER DETACHMENT. THEREFORE, THE PHYSICIAN ATTEMPTED TO USE THE GUIDEWIRE TO PUSH THE COIL OUT FROM THE TIP OF THE MICROCATHETER, BUT IT DID NOT WORK. FINALLY, THE PHYSICIAN REMOVED THE MICROCATHETER WITH INFLATING THE BALLOON CATHETER AT THE NECK OF THE ANEURYSM. HOWEVER, PART OF THE COIL WAS PROTRUDED TO THE PARENT VESSEL. SO, THE PHYSICIAN FIXED THE HANGING COIL TO THE VESSEL WALL WITH THE STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8936407 ↗
• MalfunctionJun 5, 2019Break; Break

  ANALYSIS OF THE RETURNED DEVICE REVEALED THE MAIN COIL HAD FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672603 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE COIL THOUGH THE MICROCATHETER AND THE SUBJECT COIL AND MICORCATHETER PERFORATED THE ANEURYSM. THE PHYSICIAN WAS ABLE TO REMOVE BOTH COIL AND MICORCATHETER FROM THE PATIENT¿S ANATOMY AND THE PROCEDURE WAS COMPLETED. NO KNOWN PATIENT CONSEQUENCES WERE REPORTED DUE TO THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 8536096 ↗
• MalfunctionMar 26, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE COIL WAS RETRIEVED ALONG WITH THE MICROCATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8452604 ↗
• MalfunctionMay 24, 2018Break; Break

  IT WAS REPORTED THAT WHEN THE DELIVERY WIRE WAS REMOVED FROM THE DISPENSER HOOP, THE PROXIMAL END OF THE SUBJECT COIL WAS FOUND BROKEN. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO CLINICAL CONSEQUENCES TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7540967 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE STENT ASSISTED COIL EMBOLIZATION PROCEDURE, THE PATIENT EXPERIENCED HEADACHE WHICH RESOLVED WITHOUT RESIDUAL EFFECT THE NEXT DAY. POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A MRS OF 0. ALSO, THE ANEURYSM OCCLUSION STATUS POST PROCEDURE WAS ASSESSED AS COMPLETE OBLITERATION, NO OPACIFICATION OF THE ANEURYSM OR NECK, (LEAVING NECK TO PRESERVE BRANCH IS CONSIDERED MODIFIED CLASS I). THE STUDY FACILITY ASSESSED THE HEADACHE AS BEING POSSIBLY RELATED TO THE STENT AND PROCEDURE; HOWEVER, UNKNOWN TO THE IMPLANTED COILS (SUBJECT DEVICE) AND MICROCATHETERS. DURING FOLLOW UP VISITS AT 2, 6, AND 12 MONTHS POST THE INDEX PROCEDURE, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6932979 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE STENT ASSISTED COIL EMBOLIZATION PROCEDURE, THE PATIENT EXPERIENCED HEADACHE WHICH RESOLVED WITHOUT RESIDUAL EFFECT THE NEXT DAY. POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A MRS OF 0. ALSO, THE ANEURYSM OCCLUSION STATUS POST PROCEDURE WAS ASSESSED AS COMPLETE OBLITERATION, NO OPACIFICATION OF THE ANEURYSM OR NECK, (LEAVING NECK TO PRESERVE BRANCH IS CONSIDERED MODIFIED CLASS I). THE STUDY FACILITY ASSESSED THE HEADACHE AS BEING POSSIBLY RELATED TO THE STENT AND PROCEDURE; HOWEVER, UNKNOWN TO THE IMPLANTED COILS (SUBJECT DEVICE) AND MICROCATHETERS. DURING FOLLOW UP VISITS AT 2, 6, AND 12 MONTHS POST THE INDEX PROCEDURE, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6932967 ↗
• InjurySep 15, 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 UN-RUPTURED ANEURYSM LOCATED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION. POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A MODIFIED RANKING SCALE (MRS) OF 0. AT TWO MONTHS FOLLOW-UP VISIT, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. IT WAS REPORTED THAT 6 MONTHS FOLLOW-UP POST THE INDEX PROCEDURE, THE PATIENT EXPERIENCED HEADACHE. THE HEADACHE WAS REPORTED AS ONGOING AND MEDICATION (UNKNOWN TYPE AND DOSE) WAS ADMINISTERED. ACCORDING TO THE PHYSICIAN, THE HEADACHE WAS POSSIBLY RELATED TO THE PROCEDURE AND TO THE STENT. HOWEVER IT IS UNKNOWN IF THE HEADACHE WAS RELATED TO THE IMPLANTED COILS (SUBJECT DEVICES). AT THE 6 MONTHS FOLLOW-UP THE PATIENT WAS ALSO ASSESSED HAVING A NIHSS AND MRS OF 0. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6870225 ↗
• MalfunctionAug 4, 2016Break; Break

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED AS THE COIL WAS ADVANCED INTO THE MICROCATHETER ANS THE COIL BROKE DURING PLACEMENT INTO THE MICROCATHETER. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5847886 ↗
• InjuryJul 6, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTING THAT DURING COIL EMBOLIZATION, RESISTANCE WAS EXPERIENCED WITHIN THE MICROCATHETER DISTAL TIP. MEDICAL INTERVENTION USING A SNARE DEVICE WAS NECESSARY TO RETRIEVE THE COIL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5772197 ↗
• InjuryJun 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING STENT ASSISTED COIL EMBOLIZATION OF THE ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, A THROMBUS ON THE COIL WAS NOTED AT THE ACOM WITH SLOW FLOW AT THE A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). PLATELET AGGREGATION INHIBITOR AND ANTICOAGULANT MEDICATION WERE GIVEN TO THE PATIENT. THE ADVERSE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS. THE ADVERSE EVENT WAS RELATED TO THE COIL AND TO THE PROCEDURE.

  Patient problems: Thrombosis

  MAUDE report 5724337 ↗