TARGET M0035422040Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04546540675842), received between Aug 2, 2016 and Mar 18, 2026 — classified as 7 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT COIL DETACHED ACCIDENTLY AT THE BEGINNING OF COIL DEPLOYMENT. THE SUBJECT DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634972 ↗
• MalfunctionMar 24, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE, THE SUBJECT COIL DETACHED INSIDE THE CATHETER WHILE ADVANCING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21680955 ↗
• MalfunctionJun 10, 2024Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE COIL (SUBJECT DEVICE) WAS FRACTURED 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 19506024 ↗
• InjuryMay 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM PROCEDURE, THE OPERATOR PLACED AND DETACHED THE SUBJECT COIL. AFTER HE HEARD THREE BEEPS FROM THE POWER SUPPLY, HE PULLED THE DELIVERY WIRE BACK TO CONFIRM THE DETACHMENT. NEXT, THE OPERATOR WENT TO REMOVE THE MICROCATHETER, AND THE SUBJECT COIL WAS STUCK TO IT. THE GUIDEWIRE WAS USED TO PUSH THE SUBJECT COIL OUT. 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 19435892 ↗
• MalfunctionFeb 28, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THAT DURING A EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY, UNDER RADIOSCOPIC VIEW IN PATIENT'S BODY, THE SUBJECT COIL WAS MISSED. WHEN OBSERVED OUT OF THE PATIENT'S BODY, THE ABSENCE OF THE SUBJECT COIL WAS CONFIRMED. ON FOLLOW UP THE CUSTOMER IS UNKNOWN IF THE COIL WAS ATTACHED TO THE DELIVERY WIRE DURING PREPARATION/PRIOR TO USE ON THE PATIENT. THE CUSTOMER THINKS THAT THE SUBJECT COIL DID NOT EXIT IN THE PACKAGE BEFORE INSERTION THAT IS, NOT ATTACHED IN THE PRODUCTION PROCESS. AND THEREFORE, COULD NOT FIND THE SUBJECT COIL ANYWHERE. THE CUSTOMER CONFIRMED THAT, THE SUBJECT COIL WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT. THE SUBJECT COIL 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 18799245 ↗
• MalfunctionAug 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE SURGEON REMOVED THE DELIVERY WIRE (SUBJECT DEVICE) FROM THE MICROCATHETER, THE SURGEON FELT A LITTLE RESISTANCE. WHEN THE SURGEON PULLED THE DELIVERY WIRE (SUBJECT DEVICE) OUT, HE NOTICED THAT THE DELIVERY WIRE (SUBJECT DEVICE) HAD BROKEN OFF. NO FRAGMENT LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROBLEM. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278613 ↗
• InjuryJun 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE MCA M1 ANEURYSM PROCEDURE, PHYSICIAN USED A GUIDE CATHETER TO BRING THE GUIDE WIRE INTO THE ICA, EXCHANGED THE GUIDE WIRE AND BROUGHT THE MICRO CATHETER TO THE ANEURYSM. THE COIL WAS DELIVERED INTO THE ANEURYSM BUT IT COULD NOT BE FRAMED PROPERLY, SO A STENT WAS DEPLOYED TO SUPPORT THE COIL INSIDE THE ANEURYSM. SEVERAL COILS WERE FILLED IN THE ANEURYSM. THEN THE SUBJECT COIL WAS PREPARED TO FILL BUT THE PHYSICIAN COULD NOT PUSH IT COMPLETELY INTO THE ANEURYSM. HE DECIDED TO WITHDRAW THE SUBJECT COIL, AND IT WAS FOUND FRACTURED. PHYSICIAN RETRACTED THE MICRO CATHETER WITH THE SUBJECT COIL BUT IT WAS LEFT INSIDE THE VESSEL. SO, HE DEPLOYED A STENT TO COVER THE SUBJECT COIL BUT STILL IT WASN'T COVERED COMPLETELY. HE DECIDE TO PLACE ANOTHER STENT BUT IT WAS DIFFICULT TO ADVANCE AND GOT STUCK AT THE HUB OF THE MICRO CATHETER. IT WAS REPLACED WITH ANOTHER STENT WAS SUCCESSFULLY DEPLOYED. 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 12054478 ↗
• MalfunctionMay 13, 2021Fracture; Fracture

  IT WAS INITIALLY REPORTED DURING ONE ACOMA ANEURYSM EMBOLIZATION PROCEDURE, WHEN DELIVERING THE SUBJECT COIL, THE RESISTANCE ENCOUNTERED AT THE TAIL OF MICROCATHETER AND COULD NOT BE ADVANCED. AS A RESULT ,THE OPERATOR USED OTHER COIL FROM COMPETITOR TO COMPLETE THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE RETURNED COIL (SUBJECT DEVICE) REVEALED THAT THE COIL DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816197 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL WAS STRETCHED; THEREFORE, THE SNARE WAS USED TO REMOVE THE SUBJECT COIL. THE PHYSICIAN REPLACED IT WITH A NEW COIL AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10638152 ↗
• MalfunctionSep 28, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT COIL IN THE MICROCATHETER TIP. PUSHING AND PULLING OF THE SUBJECT COIL WERE REPORTED A FEW TIMES AND THE PHYSICIAN WAS ABLE TO PLACE THE COIL INTO THE TARGET SITE; HOWEVER, THE COIL WAS PREMATURELY DETACHED WITHOUT USING THE DETACHMENT SYSTEM. THE PHYSICIAN REMOVED THE DELIVERY WIRE AND A GUIDEWIRE WAS INSERTED TO MAKE SURE THE COIL WAS NOT STUCK INSIDE THE MICROCATHETER. THE MICROCATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER PRODUCTS. THERE WERE NO PATIENT CLINICAL CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10597753 ↗
• MalfunctionApr 30, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS PREMATURELY DEPLOYED IN THE HUB OF THE MICRO CATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8565907 ↗
• MalfunctionFeb 12, 2019Migration; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO IMPLANT THE FIRST COIL (SUBJECT DEVICE) WITHOUT ANY ISSUE. THE PHYSICIAN THEN IMPLANTED THE SECOND COIL; HOWEVER, GOT TANGLED WITH THE FIRST SUBJECT COIL. BOTH COILS WERE REMOVED AND REPLACED. NO KNOWN PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8334001 ↗
• InjurySep 25, 2018Migration; Migration

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE COIL (SUBJECT DEVICE) DID NOT COMPLETELY DETACH AT FIRST AND AFTER DETACHMENT, THE COIL TAIL WAS LEFT STICKING OUT THE ANEURYSM. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907177 ↗
• MalfunctionAug 17, 2018Break; Break

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM LOCATED ON THE ACOM (ANTERIOR COMMUNICATING ARTERY) WITH SUB ARACHNOIDID BLEEDING, WHEN PLACING THE 4TH COIL (SUBJECT DEVICE), IT CAME OUT OF THE MICROCATHETER STIFF AND STRETCHED. ATTEMPT WAS MADE TO PLACE THE COIL BUT IT BROKE OFF WHEN TRYING TO REMOVE AGAIN. EVENTUALLY, THE 4TH COIL WAS RETRIEVED WITH THE MICROCATHETER, REMOVING AT THE SAME TIME THE 3RD IMPLANTED COIL THAT WAS LOCKED TO THE SUBJECT COIL. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7792365 ↗
• MalfunctionMay 31, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN THE COIL WAS ADVANCED IN THE MICROCATHETER, THE COIL GOT STUCK AND WAS DETACHED PREMATURELY. 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 7558109 ↗
• InjuryJan 25, 2018Migration or Expulsion of Device; Premature Activation; Migration or Expulsion of Device; Premature Activation

  DURING THE COIL EMBOLIZATION PROCEDURE FOR MULTIPLE ANEURYSMS (AOMA, RIGHT ICA PCOMA), IT WAS REPORTED THAT THE MAIN COIL PREMATURELY DETACHED AND DROPPED DURING REPOSITION. THE PATIENT REPORTED EXPERIENCED DISTAL VASCULAR OBSTRUCTION. AND UNSPECIFIED MEDICAL INTERVENTION WAS PROVIDED TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: Thrombosis

  MAUDE report 7220827 ↗
• InjuryOct 10, 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 OF THE UN-RUPTURED ANEURYSM, THE PATIENT EXPERIENCED HEADACHE WHICH RESOLVED WITHOUT RESIDUAL EFFECT THE NEXT DAY. POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A MRS OF 0 AND THE ANEURYSM OCCLUSION STATUS WAS ASSESSED AS 2 - RESIDUAL NECK/DOG EAR DEFINED AS THE PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL. 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 PATIENT FOLLOW UP VISITS AT 2 AND 6 MONTHS POST THE INDEX PROCEDURE, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6939378 ↗
• MalfunctionJun 7, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE SUBJECT COIL GOT STUCK AND DETACHED IN THE MICROCATHETER HUB. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6621013 ↗
• MalfunctionApr 13, 2017Premature Activation; Premature Activation

  DURING THE COIL EMBOLIZATION, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE 4TH COIL SO HE PULLED BACK THE COIL DELIVERY WIRE BUT THE 4TH COIL HAD STUCK AND TANGLED WITH THE 3RD COIL (SUBJECT COIL). THE PHYSICIAN SUSPECT THAT THE 3RD COIL MAY HAVE BEEN DETACHED AND REMAINED IN THE MICROCATHETER. IT WAS REPORTED THAT THE DETACHED COIL WAS REMOVED ALONG WITH THE 4TH COIL WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6490653 ↗
• InjuryMar 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF ANEURYSM, THERE WAS A THROMBUS PRESENT ON THE COIL DETACHMENT ZONE OF THE COIL. MULTIPLE ATTEMPTS WERE MADE TO PUT THE FIRST COIL(SUBJECT COI) AND THEN THE SECOND COIL IN THE ANEURYSM WITHOUT SUCCESS. BOTH THE COILS WERE REMOVED AND PROCEDURE WAS COMPLETED WITH A THIRD OF THE SAME DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: Thrombus

  MAUDE report 6430440 ↗
• MalfunctionAug 17, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE COIL DETACHED "PRECOSIOUSLY" IN THE MICROCATHETER AND NOT INTO THE ANEURYSM. THE USER FACILITY WAS REQUESTED TO PROVIDE ADDITIONAL INFORMATION IN REGARDS TO THE EVENT; HOWEVER, AS OF TODAY, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5881439 ↗
• MalfunctionAug 2, 2016Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL WAS UNABLE TO BE ADVANCED INTO THE MICROCATHETER AS IT APPEARED TO BE BROKEN. NO IMPACT TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5840944 ↗