TARGET M0035421020Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04546540697967), received between Jun 17, 2016 and Sep 25, 2026 — classified as 10 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Migration

  It was reported that during an aneurysm embolization procedure, a first coil (Subject coil) was successfully placed in the aneurysm. A second coil was subsequently introduced but was determined not to be a suitable fit and was retracted into the microcatheter. During retraction of the second coil, the previously implanted first coil (subject coil) was unintentionally withdrawn from its implanted position within the aneurysm. The physician reported no resistance during the event. There was an approximate 10-minute procedural delay. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892963 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during the procedure for a small approximately 2 mm blister Posterior Communicating Artery aneurysm and a wide neck Internal Carotid Artery (ICA)-T aneurysm, the physician decided to treat the smaller aneurysm. After unsuccessful attempts with two coils, the physician attempted to implant the subject coil. Even after detachment of the subject coil, it was perceived that the tip of the subject coil was still inside the microcatheter and not fully detached. Thus, a stent was deployed to cover both the aneurysms and also to tack the coil and microcatheter against the vessel wall. the physician then pulled the microcatheter leaving the subject coil detached and implanted inside the aneurysm. The subject device was replaced, and the procedure was completed successfully. There was a surgical delay of 15 min due to the reported event. No clinical consequences were reported to the patient due to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50102860 ↗
• MalfunctionFeb 19, 2026Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL 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 24385562 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL GOT STRETCHED DURING THE PUSHING AND PULLING ACTION. THUS, THE PHYSICIAN REMOVED THE SUBJECT COIL WITH MICROCATHETER FROM THE PATIENT¿S BODY. DOING SO, RESULTED IN TAKING OUT ONE MORE COIL THAT WAS IMPLANTED IN ADVANCE. 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 24278708 ↗
• MalfunctionJan 29, 2026Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL COULD NOT BE REMOVED/DETACHED DESPITE THE ACOUSTIC SIGNAL FROM THE POWER SUPPLY. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT MAIN COIL FAILED UNABLE TO DETACH WAS NOT CONFIRMED AND SUBJECT COIL WAS FOUND PREMATURELY DETACHED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218817 ↗
• InjuryNov 12, 2024Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE PROCEDURE AFTER THE SUBJECT COIL WAS DETACHED, IT WAS STUCK ON THE CATHETER TIP. THE PHYSICIAN USED A GUIDEWIRE TO SUCCESSFULLY SEPARATE THE COIL FROM THE CATHETER TIP AND PLACE THE COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664557 ↗
• InjuryJul 10, 2024Migration; Migration

  IT WAS REPORTED THAT AFTER LEFT SUPRACLINOID ANEURYSM EMBOLIZATION PROCEDURE, AFTER DETACHING THE SUBJECT COIL, WHEN PHYSICIAN ATTEMPTED TO REMOVE MICROCATHETER FROM THE ANEURYSM, THE SUBJECT COIL WAS ATTACHED TO THE MICROCATHETER AND GOT DISLODGED FROM THE ANEURYSM. THE SUBJECT COIL WAS THEN SUCCESSFULLY REMOVED FROM THE BODY USING MANUAL ASPIRATION WITH A 60CC SYRINGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712616 ↗
• InjuryApr 30, 2024Migration; Migration

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL WAS DELIVERED SUCCESSFULLY INTO THE ANEURYSM LOCATED AT THE BASILAR ARTERY. A SUBSEQUENT RUN DISCLOSED THAT THE SUBJECT COIL HERNIATED OUT OF THE ANEURYSM AND MIGRATED TO THE DISTAL LEFT POSTERIOR CEREBRAL ARTERY (PCA). ASPIRATION WAS PERFORMED TO RETRIEVE THE COIL BY THE PHYSICIAN, BUT FAILED. A RUN DISCLOSED THAT THE ANEURYSM AND BASILAR ARTERY RUPTURED. THERE WAS AN INCREASE IN THE PATIENTS BLOOD PRESSURE, SO THE PHYSICIAN STOPPED ATTEMPTING TO RETRIEVE THE SUBJECT COIL. THERE WAS A SURGICAL DELAY OF UNKNOWN TIME AND THE PATIENT'S LAST CONDITION WAS INTUBATED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; Ruptured Aneurysm

  MAUDE report 19216919 ↗
• MalfunctionMar 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL COULD NOT ADVANCE THROUGH THE MICROCATHETER. THE SUBJECT COIL WAS BROKEN WHILE WITHDRAWING FROM THE MICROCATHETER. THE PHYSICIAN REMOVED THE BROKEN PART OF THE COIL FROM 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 18918844 ↗
• MalfunctionFeb 5, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647889 ↗
• InjurySep 6, 2023Migration; Migration

  IT WAS REPORTED POST THE PCOM ANEURYSM PROCEDURE, THE SUBJECT COIL MASS DISLODGED FROM THE TREATMENT SITE RESULTING IN ANEURYSM RE-RUPTURE. THE COIL MASS WAS NOT ATTEMPTED TO BE REMOVED AND REMAINS IN THE PATIENTS M1. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON THE 28 SEP 2023 FROM THE COMPLAINT INTAKE CENTER CLARIFIED THAT THE TREATMENT OCCURRED BECAUSE OF THE ANEURYSM RE-RUPTURE AND IT WAS MONTHS AFTER INITIAL COIL TREATMENT THAT THE ANEURYSM RE-RUPTURE OCCURRED. THE COIL MIGRATION OCCURRED HOURS AFTER THE TREATMENT FOR THE ANEURYSM RE-RUPTURE. THEREFORE THE COIL MASS DISLODGING FROM THE TREATMENT SITE DID NOT RESULT IN ANEURYSM RE-RUPTURE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Ruptured Aneurysm

  MAUDE report 17691266 ↗
• InjurySep 6, 2023Migration; Migration

  IT WAS REPORTED POST THE PCOM ANEURYSM PROCEDURE, THE SUBJECT COIL MASS DISLODGED FROM THE TREATMENT SITE RESULTING IN ANEURYSM RE-RUPTURE. THE COIL MASS WAS NOT ATTEMPTED TO BE REMOVED AND REMAINS IN THE PATIENTS M1. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON THE 28 SEP 2023 FROM THE COMPLAINT INTAKE CENTER CLARIFIED THAT THE TREATMENT OCCURRED BECAUSE OF THE ANEURYSM RE-RUPTURE AND IT WAS MONTHS AFTER INITIAL COIL TREATMENT THAT THE ANEURYSM RE-RUPTURE OCCURRED. THE COIL MIGRATION OCCURRED HOURS AFTER THE TREATMENT FOR THE ANEURYSM RE-RUPTURE. THEREFORE THE COIL MASS DISLODGING FROM THE TREATMENT SITE DID NOT RESULT IN ANEURYSM RE-RUPTURE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Ruptured Aneurysm

  MAUDE report 17690980 ↗
• MalfunctionJul 27, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL PREMATURELY DETACHED IN THE MICROCATHETER LUMEN DURING THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405089 ↗
• MalfunctionApr 25, 2023Expulsion; Expulsion

  IT WAS REPORTED THAT DURING ONE POSTERIOR COMMUNICATING ARTERY PCOMA TINY ANEURYSM EMBOLIZATION CASE, THE SUBJECT COIL COULD NOT BE INSERTED INTO ANEURYSM AND IT KICKED-BACK. IT ALSO PROTRUDED INTO PARENT VESSEL. WITHDREW THE SUBJECT COIL BACK INTO MICROCATHETER AND REMOVED FROM PATIENT 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 16812381 ↗
• MalfunctionFeb 2, 2023Premature Separation; Premature Separation

  THE COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL PREMATURELY DETACHED/SEPARATED 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 16287667 ↗
• InjurySep 16, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE AFTER POSITIONING THE SUBJECT COIL PROPERLY INTO THE ANEURYSM THE SUBJECT COIL DIDN¿T DETACH AFTER MULTIPLE ATTEMPTS. WHEN THE OPERATOR TRIED TO ADVANCE THE SUBJECT COIL SLIGHTLY, THE ANEURYSM RUPTURED AND THE SUBJECT COIL DETACHED IN THE SUBARACHNOID SPACE. IT WAS ALSO REPORTED THAT A NON-STRYKER GUIDE CATHETER HAD A LEAK IN IT THAT INTRODUCED AIR INTO THE VESSEL PRIOR TO DETACHING THE SUBJECT COIL. THE PROCEDURE WAS STOPPED RIGHT AFTER THE ANEURYSM RUPTURED AND AN EVD WAS PLACED IN THE PATIENT AS A MEDICAL INTERVENTION. PATIENT OUTCOME IS UNKNOWN AT THIS MOMENT.

  Patient problems: Ruptured Aneurysm

  MAUDE report 15435759 ↗
• MalfunctionAug 30, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT A COIL EMBOLIZATION PROCEDURE WAS PERFORMED TO TREAT CEREBRAL ANEURYSM IN A-COM. WHILE ADVANCING THE SUBJECT COIL, PHYSICIAN FELT RESISTANCE IN THE MIDDLE OF THE MICROCATHETER. HE WAS UNABLE TO ADVANCE OR RETRIEVE THE SUBJECT COIL AND WHILE DOING SO, THE SUBJECT COIL GOT PREMATURELY DETACHED. THE SUBJECT COIL WAS REMOVED SAFELY FROM THE PATIENTS 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 15318385 ↗
• MalfunctionJun 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PROXIMAL CONTACT OF THE SUBJECT COIL WAS BROKEN AND WOULD NOT DETACH. ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL DELIVERY WIRE (SUBJECT DEVICE) FOUND TO BE 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 14639997 ↗
• MalfunctionMar 4, 2022Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13671262 ↗
• MalfunctionAug 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE RESISTANCE ENCOUNTERED WHEN ADVANCING THE SUBJECT COIL INSIDE THE MICROCATHETER LUMEN AND THE SUBJECT COIL WAS FRACTURED WITHIN MICROCATHETER NEAR THE DISTAL END. THE SUBJECT COIL FRACTURE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362686 ↗
• MalfunctionAug 25, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT BASILAR ARTERY ANEURYSM, THE PHYSICIAN DELIVERED A MICROCATHETER TO REACH THE TARGET LESION AND PROCEEDED TO FRAME USING COILS. WHEN DELIVERING A COIL IT WAS NOTED TO PASS THE Y-VALVE TO GO INTO MICROCATHETER BUT COULD NOT BE DELIVERED OUT OF THE MICROCATHETER DISTAL SECTION. PHYSICIAN REPLACED COIL AND ATTEMPTED PROCESS AGAIN WITH SUBJECT COIL, BUT ENCOUNTERED DIFFICULTY DELIVERING OUT OF MICROCATHETER. PHYSICIAN REPLACED SUBJECT COIL WITH ANOTHER SIMILAR DEVICE AND COMPLETED THE PROCEDURE SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE DEVICE REVEALED THAT THE SUBJECT MAIN COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10452216 ↗
• MalfunctionJul 31, 2020Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT MAIN COIL WAS BROKEN/FRACTURED. THERE WERE NO CLINICAL CONSEQUENCE TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10353849 ↗
• MalfunctionJan 27, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE COIL (SUBJECT DEVICE) WAS MECHANICALLY DEPLOYED AT THE BLEEDING POINT OF THE GASTRODUODENAL ARTERY (GDA) BEFORE ANY DETACHMENT WITH THE DETACHMENT SYSTEM. THE OPERATION WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL COIL. IT WAS REPORTED THAT THE VESSEL ANATOMY WAS VERY TORTUOUS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9635217 ↗
• MalfunctionDec 30, 2019Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL WAS BROKEN/FRACTURED INSIDE PATIENT'S ANATOMY DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9533743 ↗
• MalfunctionDec 10, 2019Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVISE FOUND THE SUBJECT COIL DELIVERY WIRE BROKEN INSIDE THE PATIENT. IT WAS REPORTED THERE WAS A 30-MINUTE DELAY IN THE PROCEDURE. THE PATIENT¿S MEDICAL CONDITION WAS GOOD AND THERE WAS NO ADVERSE EVENT. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9447477 ↗