TARGET M0035473080Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540676436), received between Sep 1, 2017 and Mar 4, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 18 DAYS POST PROCEDURE, FOLLOWING IMPLANTATION WITH SUBJECT COILS, THE PATIENT EXPERIENCED SEVERE PROGRESSIVE HEADACHES AND SEIZURE REQUIRING MEDICATIONS. TWO DAYS POST DISCHARGE, THE PATIENT WAS READMITTED FOR INCREASED HEADACHES. A MULTIFOCAL RIGHT HEMISPHERIC MENINGOENCEPHALIC CONDITION WHOSE LOCATION AND APPEARANCE COMPATIBLE WITH A NICE SYNDROME WAS OBSERVED IN BRAIN MAGNETIC RESONANCE IMAGING (MRI). THE MANUFACTURER HAS REQUESTED PATIENT STATUS; HOWEVER, AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Epilepsy; Headache

  MAUDE report 18825787 ↗
• MalfunctionJul 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT THE SUBJECT COIL PUSHER WIRE BROKE DURING INTRODUCING THE COIL INTO THE MICROCATHETER. 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 17385440 ↗
• MalfunctionJun 28, 2022Fracture; Expulsion; Fracture; Expulsion

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THIRD OF THE COIL (SUBJECT DEVICE) WAS INSERTED INTO ANEURYSM, THE OPERATOR FOUND NO REACTION FROM THE MANIPULATION. WHEN CHECKED UNDER DSA, IT WAS FOUND THAT THE COIL (SUBJECT DEVICE) WAS FRACTURED. THE OPERATOR TRIED TO PUSH AND PULL THE COIL (SUBJECT DEVICE) SEVERAL TIMES, IT COULD NOT MOVE. SO THE OPERATOR RETRACED REST OF THE COIL (SUBJECT DEVICE) WITH DELIVERY WIRE OUT, AND USED A GUIDEWIRE TO PUSH PART OF THE COIL (SUBJECT DEVICE) WHICH WAS OUT OF THE ANEURYSM TO GO INTO ANEURYSM SLOWLY. 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 14844396 ↗
• InjuryApr 25, 2022Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT NEURO ENDOVASCULAR COIL EMBOLIZATION PROCEDURE WAS PLANNED FOR RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM. IT WAS REPORTED THAT DURING THE PROCEDURE PHYSICIAN DEPLOYED FEW COILS INSIDE THE ANEURYSM. FIRST ATTEMPT OF COILING WITH THE SUBJECT COIL WAS UNSUCCESSFUL, SO PHYSICIAN REMOVED AND RE-SHEATHED IT AND LOAD THE SAME COIL AFTER REPOSITIONING THE MICRO CATHETER. AFTER REPOSITIONING SUBJECT COIL INSIDE THE ANEURYSM BEFORE DETACHMENT ATTEMPT WAS MADE WITH DETACHMENT SYSTEM, THE SUBJECT COIL ABNORMALLY STREAKED IN ITS MORE DISTAL PART AND THEN BROKE OFF IN THE MICRO CATHETER IN ITS MORE PROXIMAL PART. SUBJECT COIL COULD NOT BE REMOVED WITH A LASSO, AND STENT WAS REQUIRED TO PLATE THE FLOATING PORTION OF THE SUBJECT COIL AGAINST THE ARTERY WALL AT THE CAROTID TERMINATION. BECAUSE OF THE REPORTED ISSUE, PARTIAL ENDOVASCULAR TREATMENT OF THE ANEURYSM ALONG WITH SPIRAL OVERFLOW OPPOSITE THE POSTERIOR COMMUNICATING ARTERY WERE NOTED AND DOUBLE ANTIPLATELET AGGREGATION TREATMENT WAS ALSO REQUIRED. PATIENT RECEIVED ASPEGIC IV + CANGRELOR IV PER PROCEDURE. PATIENT WILL BE RECEIVING KARDEGIC AND BRILIQUE 3 MONTHS AND THEN KARDEGIC FOR 6 MONTHS. NO CLINICAL CONSEQUENCE

  Patient problems: Foreign Body In Patient

  MAUDE report 14196650 ↗
• MalfunctionSep 1, 2021Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL 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 12406732 ↗
• InjurySep 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT. POST-PROCEDURE THE PATIENT WAS NEUROLOGICALLY ASSESSED AS HAVING A MRS (MODIFIED RANKING SCALE) OF 0. 16 DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED HEADACHE THAT LASTED 9 DAYS. MEDICATIONS PROCHLORPERAZINE 10 MG IV AND DIPHENHYDRAMINE 12.5 MG WERE ADMINISTERED ON THE 19 DAYS POST-PROCEDURE AS OUT-PATIENT IN EMERGENCY DEPARTMENT (ED) IN ORDER TO TREAT THE HEADACHE. PRESCRIPTIONS FOR COMPAZINE 10 MG PO AND BENADRYL 25 MG PO WERE GIVEN TO THE PATIENT WHEN DISCHARGED FROM ED. THE HEADACHE WAS RESOLVED WITHOUT ANY RESIDUAL EFFECTS. ACCORDING TO THE PHYSICIAN, THE HEADACHE WAS PROBABLY RELATED TO THE PROCEDURE AND TO THE STENT. IT WAS UNKNOWN IF THE HEADACHE WAS RELATED TO THE IMPLANTED COILS. THE PATIENT WAS ASSESSED HAVING A MRS OF 0 AT 2-MONTH POST-INDEX PROCEDURE.

  Patient problems: Headache; Visual Disturbances

  MAUDE report 6839354 ↗