TARGET M0035425150Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540675965), received between Dec 4, 2018 and Jun 30, 2026 — classified as 1 death, 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (7 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.

• MalfunctionJun 30, 2026Fracture; Expulsion; Premature Separation

  It was reported that during coronary artery fistula procedure, planned for coil embolization. After delivering the guiding catheter to the target position via the radial artery, the physician delivered the microcatheter to the fistula opening. A Stryker coil was delivered, positioned, and successfully detached. The physician then delivered an additional coil. After flushing, delivery was initiated with no resistance. After inserting, the physician was dissatisfied with the result and attempted to reposition the coil 3 times, still unsatisfactory. The physician then attempted to retrieve the subject coil but found it had already detached and could not be retrieved. Angiography confirmed the subject coil had not migrated. The physician then withdrew the delivery wire, and after taken out it was found a metal wire connected at tip of the delivery wire. The physician then used coils and a microcatheter of another brand to continue inserting until satisfied, then concluded the procedure. After the patient went back to ward, the nurse discovered a metal wire at the radial artery occlusion area (external the skin). Following angiography revealed a wire-like structure extending from corona

  Patient problems: Foreign Body In Patient

  MAUDE report 25669776 ↗
• MalfunctionJan 9, 2025Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT DEVICE WAS PREMATURELY DETACHED/SEPARATED 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 21117168 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST STUDY PROCEDURE, THE PATIENT EXPERIENCED INTRAPROCEDURAL THROMBUS AS MILD PLATELET AGGREGATION WAS NOTED OUTSIDE THE COIL MASS. BASED ON THE FINDINGS, A BOLUS INFUSION OF INTEGRILIN OVER 10 MINUTES WAS ORDERED INTO LEFT ICA (INTERNAL CAROTID ARTERY). FOLLOW UP IMAGING WAS PERFORMED, AND NO FILLING DEFECT WAS SEEN TO SUGGEST PLATELET AGGREGATION. THE ADVERSE EVENT WAS RESOLVED, WITHOUT SEQUELAE AND THE PATIENT WAS NEUROLOGICALLY STABLE AT DISCHARGE. FROM A MEDICAL OPINION PERSPECTIVE, THE ADVERSE EVENT (INTRAPROCEDURAL THROMBUS) WAS POSSIBLY RELATED TO THE SUBJECT COIL DEVICE, AND CAUSALLY RELATED TO THE INDEX PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18080422 ↗
• InjuryApr 19, 2022Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT A STENT ASSISTED COILING PROCEDURE WAS PERFORMED IN A PATIENT WITH LEFT ICA ( INTERNAL CAROTID ARTERY) C5 (SEGMENT) ANEURYSM. DURING THE PROCEDURE, WHEN THE PHYSICIAN INSERT THE SUBJECT COIL INTO THE ANEURYSM, AFTER HALF OF THE SUBJECT COIL WAS FILLED INTO THE ANEURYSM, A FRACTURED LOOP OF THE SUBJECT COIL DROPPED OUT OF THE ANEURYSM. SO THE PHYSICIAN DEPLOYED A STENT TO SUPPORT AND CONTINUED TO FILL THE SUBJECT COIL. LATER WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE SUBJECT COIL USING A POWER SUPPLY SYSTEM, HE FOUND THAT THE SUBJECT COIL WAS NOT DETACHED. THE PHYSICIAN REPLACED THE POWER SUPPLY SYSTEM FOR THREE TIMES TO DETACH THE SUBJECT COIL BUT WAS STILL NOT ABLE TO DETACH THE SUBJECT COIL. THEREFORE THE PHYSICIAN DECIDED TO RETRIEVE THE SUBJECT COIL AND FOUND THAT THE SUBJECT COIL WAS FRACTURED AND THE FRACTURED PART OF THE SUBJECT COIL REMAINED INSIDE THE PATIENTS VASCULAR ANATOMY. THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE FRACTURED SUBJECT COIL BACK INTO THE ANEURYSM, DURING THIS ADJUSTMENT, THE TIP OF THE MICROCATHETER MIGRATED OUT OF THE ANEURYSM AND THE FRACTURE SUBJECT COIL WAS TAKEN TO THE VESSEL AS WELL. THE PHYSICIAN DEPLOYED ANOTHER STENT TO PRES

  Patient problems: Foreign Body In Patient

  MAUDE report 14139703 ↗
• InjuryDec 25, 2021Fracture; Premature Separation; Fracture; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE IN CASE OF IC-PC CEREBRAL ANEURYSM EMBOLIZATION FOR SAH, THE COIL (SUBJECT DEVICE) ENCOUNTERED RESISTANCE AT THE DISTAL OF THE MICROCATHETER THAT IT WAS DIFFICULT TO PLACE. THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED WHEN IT WAS TRIED TO BE RETRIEVED. THE PREMATURELY DETACHED COIL (SUBJECT DEVICE) WAS REMOVED BY USING THE SNARE, AND SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT RE-EMBOLIZATION. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13085563 ↗
• MalfunctionJun 29, 2021Migration; Migration

  IT WAS REPORTED THAT THE STENT ASSISTED COIL EMBOLIZATION PROCEDURE WAS PERFORMED FOR ICA (INTERNAL CAROTID ARTERY) PCOMP (POSTERIOR COMMUNICATING ARTERY) WIDE NECK ANEURYSM. AFTER DELIVERING THE MICROCATHETER WITH GUIDEWIRE INTO THE LUMEN OF TARGETED VESSEL, PHYSICIAN STARTED ANEURYSMAL COIL EMBOLIZATION. THE SUBJECT COIL WAS PLACED AND DEPLOYED AS EXPECTED. BUT SUBJECT COIL LOOP HAS MIGRATED TO THE PARENT VESSEL AS THE NECK OF THE ANEURYSM WAS TOO WIDE. SO THE PHYSICIAN HAS DECIDED TO DEPLOY THE STENT FIRST TO SUPPORT THE COIL MASS AT THE NECK OF THE ANEURYSM. 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 12086660 ↗
• MalfunctionJun 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE OF MCA ANEURYSM EMBOLIZATION, A MICROCATHETER WAS USED TO BUILD ACCESS AND DELIVERED A COIL (SUBJECT DEVICE) TO GO INTO THE ANEURYSM AND PREPARED TO DETACH IT. THE TAIL OF DELIVERY WIRE WAS INSERTED TO GO INTO THE DETACHMENT DEVICE AND THE INSTILLATION WAS NORMAL. THE DETACHMENT BUTTON WAS PRESSED AND WAITED FOR MORE THAN 10 SECONDS BUT THE SUBJECT COIL WAS NOT DETACHED. SO, THE DELIVERY WIRE WAS TAKEN OUT AND TRIED TO INSERT AGAIN AND THE DETACHMENT ATTEMPT WAS MADE AGAIN, BUT THE COIL WAS STILL NOT ABLE TO BE DETACHED. FINALLY WHEN THE PHYSICIAN PREPARED TO TAKE THE TAIL OF DELIVERY WIRE OUT OF DETACHMENT DEVICE, IT WAS FOUND THAT THE TAIL OF DELIVERY WIRE OF THE SUBJECT DEVICE WAS FRACTURED IN THE DETACHMENT DEVICE. 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 12063672 ↗
• MalfunctionJun 18, 2021Premature Separation; Premature Separation

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) WAS STRETCHED AND PREMATURELY DEPLOYED INSIDE THE PATIENT. THE COIL DELIVERY WIRE WAS ALSO NOTED TO BE KINKED AND BENT. 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 12029304 ↗
• MalfunctionApr 22, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN REPORTED THAT THE SUBJECT COIL HAD ELASTICED AND WAS DIFFICULT TO PUSH. ANALYSIS OF THE RETURNED SUBJECT COIL REVEALED THAT THE DEVICE HAD 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 11711256 ↗
• DeathMar 2, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE PHYSICIAN PLACED THE SUBJECT COIL INSIDE THE PATIENT¿S ANEURYSM, ITS END LOOPS WERE STICKING OUT. WHILE THE PHYSICIAN TRIED TO READJUST THE SUBJECT COIL, IT DETACHED PREMATURELY FROM ITS DELIVERY WIRE. THE PHYSICIAN USED A RETRIEVER AS A SNARE DEVICE TO RETRIEVE THE SUBJECT COIL FROM THE PATIENT¿S ANATOMY. WHILE THE PHYSICIAN TRIED TO RE-ACCESS THE ANEURYSM SEVERAL TIMES, THE ANEURYSM GOT PERFORATED. THE PATIENT WAS TREATED FOR THE PERFORATION OF ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAS PASSED AWAY AND THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 11399420 ↗
• MalfunctionNov 9, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL GOT DETACHED WHILE PULLING BACK INTO THE 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 10814438 ↗
• MalfunctionAug 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS STRETCHED. IT WAS INITIALLY REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS STRETCHED. ANALYSIS OF THE DEVICE REVEALED THAT THE SUBJECT MAIN COIL WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10389216 ↗
• InjuryDec 4, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN WAS TRYING TO DETACH A COIL (SUBJECT DEVICE) WITH A DETACHMENT SYSTEM BUT IT SOUNDS A LONG BEEP AND THE PHYSICIAN DID NOT TRY TO PRESS THE DETACHMENT BUTTON AGAIN. WHEN TRYING TO PULL BACK ON THE COIL DELIVERY WIRE, IT WAS NOTICED THAT THE COIL WAS STILL ATTACHED. AFTER SEVERAL UNSUCCESSFUL MANIPULATIONS, IT WAS NOTICED WHILE TRYING TO RETRACT THE COIL OUT OF THE MICOCATEHTER, THAT 6-8 COM OF THE COIL WAS PROTRUDING OUT OF THE ANEURYSM. STENTING WAS UNDERTAKEN TO TRY TO TACK DOWN THE PROTRUDING COIL AGAINST THE INTERNAL CAROTID ARTERY (ICA). THE MICROCATHETER WAS THEN PULLED BACK AND THE COIL WAS THEN DETACHED SUCCESSFULLY. ANOTHER STENT WAS PLACED TO TACK DOWN THE PROTRUDING COIL. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8129497 ↗