TARGET M0035475150Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540676504), received between Oct 29, 2018 and Jan 13, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL WAS PREMATURELY DETACHED/SEPARATED 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 24064082 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE PROXIMAL PORTION OF THE PUSHER GOT BROKEN/FRACTURED AND REMAINED INSIDE THE RELEASE MECHANISM. 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 23824910 ↗
• MalfunctionFeb 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING RIGHT ICA (INTERNAL CAROTID ARTERY) C5 ANEURYSM EMBOLIZATION PROCEDURE THE OPERATOR FLUSHED AND DELIVERED THE COIL (SUBJECT DEVICE), BUT THE COIL (SUBJECT DEVICE) COULD NOT BE ADVANCED TO THE DISTAL OF THE MICROCATHETER. DURING THE WITHDRAWAL, THE COIL (SUBJECT DEVICE) GOT STUCK AND COULD NOT BE RETRACTED OUT OF THE MICROCATHETER. WHEN THE OPERATOR ADDED SOME FORCE TO PULL THE COIL (SUBJECT DEVICE) OUT, THE MIDDLE OF THE COIL (SUBJECT DEVICE) DELIVERY WIRE WAS FRACTURED. 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 16456853 ↗
• MalfunctionNov 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, IT WAS A DIFFICULTY AND HOOKY TO INSERT AND ADVANCE THE SUBJECT COIL. WHEN PULLING BACK THE SLEEVE, THE SUBJECT COIL IS THEN FINALLY TORN OFF. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845605 ↗
• InjuryApr 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT ENDONEUROVASCULAR ANEURYSMAL COIL EMBOLIZATION WAS PLANNED FOR RUPTURED ANEURYSM CASE. DURING THE PROCEDURE IT WAS REPORTED THAT THE SUBJECT COIL WAS ¾ DEPLOYED IN A RUPTURED ANEURYSM WHEN THE PHYSICIAN NOTICED IT WAS NO LONGER EASY TO DEPLOY. PHYSICIAN TRIED TO RETRACT THE SUBJECT COIL. IT WOULD NOT DEPLOY OR COME BACK INTO THE MICROCATHETER. PHYSICIAN HAD TO PULL MICROCATHETER ALL THE WAY OUT LEAVING THE SUBJECT COIL. IT SNAPPED OFF DELIVERY WIRE AND WAS LEFT HANGING IN THE MCA (MIDDLE CEREBRAL ARTERY). STENT WAS USED TO PIN THE COIL INTO MCA (MIDDLE CEREBRAL ARTERY). TWO-HOUR OF SURGICAL DELAY WAS NOTED DUE TO THE REPORTED ISSUE AND THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THE TIME OF EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14060380 ↗
• InjuryJan 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL TRIAL PROCEDURE TO TREAT A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE PATIENT HAD HEMIANOPIA AND DELIRIUM. ON IMAGING, OCCIPITAL MICRO EMBOLIC INFARCTS WERE SEEN WHICH RESULTED IN PROLONGED HOSPITALIZATION FOR THE PATIENT. THE EVENT WAS TREATED WITH PHYSIOTHERAPY AND ORAL OLANZAPIN 5 MG FOR DELIRIUM FOR 5 DAYS AND RECOVERED. IN THE PHYSICIAN'S OPINION, THE EVENT WAS POSSIBLY RELATED TO THE SUBJECT DEVICE AND OTHER STRYKER DEVICES USED IN THE PROCEDURE.

  Patient problems: Cognitive Changes; Visual Impairment

  MAUDE report 13262428 ↗
• MalfunctionJul 9, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE LEFT ACOMA ANEURYSM EMBOLIZATION PROCEDURE, A GUIDEWIRE AND GUIDE CATHETER WERE USED TO SELECT THE ICA C2. THE GUIDEWIRE WAS RETRACTED TO INSERT THE SUBJECT COIL. IT WAS REPORTED THAT FRICTION WAS NOTED INSIDE THE SHAFT WHEN ADVANCING THE SUBJECT COIL IN THE PROXIMAL OF THE MICROCATHETER. WHEN THE SUBJECT COIL WAS RETRACTED, IT WAS NOTED THAT IT GOT FRACTURED AT THE DETACHMENT ZONE AND GOT SEPARATED FROM ITS DELIVERY WIRE INSIDE THE MICROCATHETER. THE SEPARATED SUBJECT COIL WAS REMOVED ALONG WITH THE REMOVAL OF MICROCATHETER. 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 12145646 ↗
• MalfunctionAug 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO DEPLOY THE SUBJECT COIL, THE DETACHMENT SYSTEM GAVE THREE POSITIVE BEEPS CONFIRMING THE DETACHMENT OF THE COIL; HOWEVER, WHEN THE PHYSICIAN PULLED THE DELIVERY WIRE OUT OF THE MICROCATHETER, THE PHYSICIAN NOTICED A THIN WIRE HANGING FROM THE DISTAL END OF THE DELIVERY WIRE. THE PHYSICIAN LOST ACCESS, SO HE ATTEMPTED TO RE-ACCESS WITH A GUIDEWIRE BUT MET A TREMENDOUS AMOUNT OF RESISTANCE AT VERY DISTAL END OF THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER FROM THE PATIENT ANATOMY AND FOUND THAT PART OF THE COIL WAS BROKEN OFF AND WAS IN THE MICROCATHETER. ALL BROKEN PART OF THE COIL WAS REMOVED WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER 4 COILS USING THE SAME MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10365695 ↗
• MalfunctionDec 26, 2019Fracture; Premature Separation; Fracture; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THE DELIVERY WIRE BROKEN AND THE COIL DETACHED. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520596 ↗
• InjuryNov 19, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED IN THE CATHETER WHILE INSIDE THE PATIENT. THE PRE-DETACHED COIL SEGMENT WAS REMOVED WITH SUCCESSFULLY WITH A STENT, CAUSING A TWO HOUR DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO KNOWN CLINICAL CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9344647 ↗
• MalfunctionAug 14, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE NEURORADIOLOGIST WAS ABLE TO PLACE THE COIL IN THE ANEURYSM WITHOUT ANY PATIENT CLINICAL CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8894346 ↗
• MalfunctionFeb 14, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE COIL (SUBJECT DEVICE) WAS ADVANCED IN THE MICROCATHETER, THE COIL DETACHED PREMATURELY INTO THE MICROCATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8341555 ↗
• InjuryOct 29, 2018Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION FOR A RUPTURED ANEURYSM FOR A PATIENT THAT WAS IN A POOR CLINICAL CONDITION (HUNT AND HESS GRADE 5), THE SUBJECT COIL WAS STRETCHED WHEN REPOSITIONED. DUE TO THE STRETCHED COIL, A VERTEBRAL SACRIFICE HAD TO BE PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Code Available; Thrombosis

  MAUDE report 8017629 ↗