TARGET M0035473060Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540676429), received between Aug 9, 2016 and May 5, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A VERTEBRAL ARTERY SEGMENT ANEURYSM, THE PHYSICIAN USED A GUIDEWIRE TO CARRY THE MICROCATHETER TO THE TARGET LOCATION SUPERSELECTIVELY AND PREPARED TO IMPLANT COILS, THE SUBJECT COIL ENCOUNTERED SIGNIFICANT RESISTANCE WITHIN THE MICROCATHETER AFTER BEING PUSHED FROM THE INTRODUCING SHEATH. DESPITE REPEATED ADJUSTMENTS BY THE PHYSICIAN, THE SUBJECT COIL COULD NOT BE ADVANCED. SUBSEQUENTLY, THE PHYSICIAN WITHDREW THE SUBJECT COIL FOR EXTERNAL EXAMINATION AND FOUND THAT IT HAD BEEN STRETCHED AND DETACHED PREMATURELY. 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 25086833 ↗
• MalfunctionMay 8, 2025Device Misassembled During Manufacturing /Shipping; Component Misassembled; Device Misassembled During Manufacturing /Shipping; Component Misassembled

  IT WAS REPORTED THE POSITION OF THE RADIOPACITY MARKER ON THE SUBJECT COIL SEEMED MISPLACED. THE SUBJECT COIL SEEMS TO BE MORE AHEAD OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SUBJECT DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988688 ↗
• MalfunctionMar 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE FLUORO-SAVER MARKER AND THE MICROCATHETER Y-CONNECTOR WERE ALIGNED; HOWEVER, THE SUBJECT COIL HAD ALREADY ADVANCED OUT OF THE MICROCATHETER DISTAL TIP. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612628 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE FOR A RUPTURED ANEURYSM, PHYSICIAN USED THE SUBJECT COIL AND FLOW DIVERTING STENT TO TREAT THE PATIENT. POST PROCEDURE ON (B)(6) 2023 PATIENT WAS READMITTED DUE TO FINE MOTOR DISTURBANCE OF RIGHT HAND SINCE (B)(6) 2023. FACIALIS WEAKNESS ON RIGHT HAND. MULTIFOCAL SUBCORTICAL EDEMA WAS NOTICE IN THE CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING). ACCORDING THE PHYSICIAN IT IS CAUSED BY CONTACT ALLERGY (NEW) TYPE IV TO NICKEL + COBALT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Cerebral Edema; Neuropathy

  MAUDE report 17327960 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE FOR A RUPTURED ANEURYSM, PHYSICIAN USED THE SUBJECT COIL AND FLOW DIVERTING STENT TO TREAT THE PATIENT. POST PROCEDURE ON (B)(6) 2023, PATIENT WAS READMITTED DUE TO FINE MOTOR DISTURBANCE OF RIGHT HAND SINCE (B)(6) MAY, FACIALIS WEAKNESS ON RIGHT HAND. MULTIFOCAL SUBCORTICAL EDEMA WAS NOTICE IN THE CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING). ACCORDING THE THE PHYSICIAN IT IS CAUSED BY CONTACT ALLERGY (NEW) TYPE IV TO NICKEL + COBALT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Cerebral Edema; Neuropathy

  MAUDE report 17327361 ↗
• InjuryNov 8, 2022Premature Separation; Premature Separation

  ¿IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN DETACHED THE SUBJECT COIL AND TRIED TO RETRACT THE DELIVERY WIRE. WHILE RETRACTION, IT WAS NOTICED THAT THE SUBJECT COIL WAS NOT DETACHED AND CAME OFF ALONG WITH THE DELIVERY WIRE. PHYSICIAN TRIED TO RETRACT THE DELIVERY WIRE BUT THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE PATIENT¿S ANATOMY. A SNARE DEVICE WAS USED TO REMOVE THE SUBJECT COIL. 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 15753016 ↗
• MalfunctionJun 30, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER THE COIL (SUBJECT DEVICE) WAS INSERTED, RESISTANCE WAS FELT INSIDE THE MICROCATHETER AND THE SUBJECT COIL WAS RETRACTED. ONCE REMOVED, THE SUBJECT COIL WAS FOUND BROKEN. THE COIL WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10215676 ↗
• MalfunctionApr 30, 2019Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE COIL (SUBJECT DEVICE) BROKE. THE CATHETER WAS CHANGED, THE COIL REMOVED AND NOT USED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8567529 ↗
• MalfunctionNov 5, 2018Break; Premature Separation; Break; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE COIL (SUBJECT DEVICE) WAS REPOSITIONED IN THE ANEURYSM; HOWEVER, WAS NOTED TO BE STRETCHED. DURING RETRIEVAL, THE COIL WAS DETACHED MECHANICALLY INSIDE THE MICROCATHETER AND ALSO WAS NOTED TO BE BROKEN. THE COIL WAS REMOVED WITH THE MICROCATHETER FROM THE PATIENT¿S BODY. THE COIL AND MICROCATHETER WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040177 ↗
• InjuryNov 21, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE THE COIL PREMATURELY SEPARATED AT THE DETACHMENT ZONE. THE PHYSICIAN SAFELY REMOVED THE COIL FROM THE PATIENT'S BODY WITH A RETRIEVAL DEVICE WITHOUT CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6119355 ↗
• MalfunctionAug 9, 2016Break; Break

  IT WAS REPORTED THAT UPON INSERTING THE COIL INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN OBSERVED THAT THE 5MM DISTAL SECTION OF THE COIL WAS FRACTURED. THE COIL WAS REPLACED WITH ANOTHER SIMILAR COIL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5856939 ↗