TARGET M0035443060Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07613252600329), received between May 17, 2016 and Dec 21, 2022 — classified as 5 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2022Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL BROKE/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030416 ↗
• MalfunctionNov 29, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL COULD NOT BE ADVANCED TO DISTAL OF MICROCATHETER EVEN AFTER SEVERAL TRIES. THE OPERATOR FOUND THE SUBJECT COIL DETACHED INSIDE THE MICROCATHETER DURING DELIVERY. 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 15881099 ↗
• MalfunctionMar 20, 2022Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL WAS PREMATURELY DETACHED DURING USE. 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 13831807 ↗
• MalfunctionNov 29, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT ENDOVASCULAR COILING OF ANTERIOR COMMUNICATING ARTERY (A COM) ANEURYSM WAS PERFORMED IN A PATIENT. DURING THE PROCEDURE INITIALLY GUIDE CATHETER AND MICROCATHETER WERE USED TO REACH THE TARGET LESION, WHEN ATTEMPTED TO DELIVER THE SUBJECT COIL TO THE TARGET LESION, THE SUBJECT COIL DETACHED PREMATURELY AND GOT STRETCHED INSIDE THE LUMEN OF THE MICROCATHETER. THE SUBJECT COIL WAS RETRACTED OUT OF THE PATIENT'S VASCULAR ANATOMY. 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 12882795 ↗
• MalfunctionNov 23, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCESS OF ENDOVASCULAR COILING OF A.COM ANEURYSM WHILE THE COIL (SUBJECT DEVICE) INTRODUCED INSIDE ANEURYSM IT DETACHED SPONTANEOUSLY AND ELONGATED INSIDE MICRO CATHETER. 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 12866778 ↗
• MalfunctionSep 16, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, RESISTANCE WAS FELT WHEN THE SUBJECT COIL WAS GUIDED INTO THE MICROCATHETER. WHEN THE SUBJECT COIL WAS ABOUT TO COME OUT OF THE TIP OF THE MICROCATHETER, IT GOT PREMATURELY DETACHED. THEREFORE, IT WAS COLLECTED TOGETHER WITH THE ENTIRE 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 12478950 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE MCA ANEURYSM WAS RE-RUPTURED AFTER CLIPPING AND PHYSICIAN SWITCHED TO COIL EMBOLIZATION. A MICROCATHETER WAS USED TO REACH THE TARGET SITE AND 11 COILS WERE FILLED IN THE ANEURYSM BEFORE THE SUBJECT COIL. WHILE USING THE SUBJECT COIL PHYSICIAN FOUND IT DIFFICULT TO INSERT IT INTO THE MICROCATHETER BUT WAS ABLE TO ADVANCE IT TO THE ANEURYSM. WHILE REACHING MIDDLE OF THE ANEURYSM THE SUBJECT COIL GOT STRETCHED AND A SNARE DEVICE WAS USED TO RETRIEVE THE SUBJECT COIL. 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 12176352 ↗
• MalfunctionJun 28, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL BROKEN/FRACTURED DURING USE. 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 12081779 ↗
• MalfunctionJun 8, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PROXIMAL SECTION OF THE COIL (SUBJECT DEVICE) STRETCHED AND PREMATURELY DETACHED INSIDE THE MICRO CATHETER WHILE EMBOLIZING AN UNRUPTURED CEREBRAL ANEURYSM. THE SUBJECT DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958445 ↗
• MalfunctionApr 13, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DELIVERY WIRE WOULD NOT ADVANCE OR PULL BACK THROUGH THE MICROCATHETER AND PARTIALLY DEPLOYED ONCE PLACED INSIDE THE ANEURYSM. THE SUBJECT COIL AND MICROCATHETER WERE SUCCESSFULLY REMOVED FROM THE ANEURYSM. THE PREVIOUS COIL THAT WAS ALREADY IN THE ANEURYSM WAS NOT DISPLACED BY THE REMOVAL OF THE SUBJECT COIL. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654396 ↗
• MalfunctionJan 11, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE OF ENDOVASCULAR ANEURYSM STENT ASSISTED COIL EMBOLIZATION, DURING PACKING ANEURYSM WHILE ADVANCING THE COIL (SUBJECT DEVICE) INTO THE MICROCATHETER MID SECTION OF THE MAIN COIL FRACTURED AND DISTAL PORTION GOT STRETCHED INSIDE THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO REMOVE ALL FRACTURED COIL PARTS FROM THE PATIENTS ANATOMY. 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 11145926 ↗
• InjurySep 18, 2019Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT THE COIL(SUBJECT DEVICE) DETACHED PREMATURELY AT THE DETACHMENT ZONE INSIDE THE PATIENT, A SNARE DEVICE WAS ATTEMPTED TO RETRIEVE THE COIL, BUT A PART OF THE COIL WAS LEFT IN THE ANEURYSM. THE BROKEN PORTION OF THE COIL MIGRATED INTO THE NEURO ANATOMY. THE PHYSICIAN LEFT THE COIL PARTIALLY IN VESSEL ICA (INTERNAL CAROTID ARTERY) AND ACA (ANTERIOR CEREBRAL ARTERY) AND COMPLETED THE PROCEDURE. THE PHYSICIAN STATED THAT THE PATIENT¿S POOR CONDITION POST PROCEDURE WAS NOT RELATED TO UNRETRIEVED COIL IN THE PARENT VESSEL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9082963 ↗
• MalfunctionJun 24, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A CEREBRAL ANEURYSM PROCEDURE, THE SUBJECT COIL PREMATURELY DETACHED IN THE MICROCATHETER WHEN PULLED. THE MICROCATHETER AND SUBJECT COIL WERE REMOVED TOGETHER AND REPLACED WITH OTHER UNITS. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8729607 ↗
• MalfunctionDec 4, 2018Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE COIL DELIVERY WIRE WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8131621 ↗
• MalfunctionNov 15, 2018Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FELT A STRIKE WHEN INSERTING THE COIL INTO THE MICROCATHETER AND THE DELIVERY WIRE OF THE COIL WAS BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8076136 ↗
• MalfunctionSep 19, 2018Break; Break

  AFTER REVIEWING THE INVESTIGATION, IT WAS REVEALED THAT THE MAIN COIL WAS BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7891915 ↗
• MalfunctionAug 23, 2018Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE COIL DELIVERY WIRE WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7811746 ↗
• MalfunctionAug 15, 2018Degraded; Migration; Degraded; Migration

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED WHEN THE PHYSICIAN PULLED THE MICROCATHETER OUT, THE DETACHED COIL (SUBJECT DEVICE) CAME TOGETHER WITH THE MICROCATHETER. EVEN THOUGHT, IT WAS CONFIRMED UNDER THE FLUOROSCOPY THAT THE COIL WAS SUCCESSFULLY DETACHED IN THE ANEURYSM AND IT LOOKED LIKE THERE WAS A LITTLE SPACE BETWEEN THE COIL AND THE MICROCATHETER TIP. SO THE DETACHED COIL WAS RETRIEVED WITH THE MICROCATHETER. UPON REVIEW ON THE BACK TABLE, IT LOOKED LIKE THE COIL WAS SOMEHOW ATTACHED TO THE MICROCATHETER. AND STRETCH RESISTANCE MATERIAL IN THE COIL SEEMS TO BE MELTED TO THE MICROCATHETER TIP. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7787243 ↗
• MalfunctionAug 15, 2018Break; Break

  DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE MAIN COIL WAS BROKEN. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7787175 ↗
• MalfunctionJul 31, 2018Break; Break

  IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE WITH THE SUBJECT COIL, ¿THE DOCTOR PRESSED THE SHEATH AGAINST THE HUB OF THE MICROCATHETER TOO MUCH SO THE TIP OF THE COIL BROKE¿. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7737478 ↗
• InjuryMay 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING PLACEMENT OF THE FINISHING COIL (SUBJECT DEVICE), THE COIL WAS REPOSITIONED AND STRETCHED AND IT WAS REPORTED THE COIL WAS COMPLETELY REMOVED FROM THE PATIENT WITH A SNARE DEVICE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555471 ↗
• MalfunctionMay 22, 2017Break; Break

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE MAIN COIL WAS BROKEN/FRACTURED. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6583698 ↗
• MalfunctionDec 7, 2016Break; Break

  ANALYSIS OF THE RETURNED COIL REVEALED THAT IT WAS BROKEN OFF FROM THE DELIVERY WIRE. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6152107 ↗
• InjuryJun 29, 2016Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) DURING REPOSITIONING, THE PROXIMAL SECTION OF THE COIL STRETCHED, BROKE, AND PROTRUDED FROM THE ANEURYSM. THERE HAS BEEN NO RE-INTERVENTION WITH STENTING AS OF TODAY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5760647 ↗
• MalfunctionJun 28, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5755583 ↗