TARGET M0035443560Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613252600343), received between Nov 21, 2019 and May 21, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT SUBJECT COIL WAS PREMATURELY DETACHED DURING USE IN PATIENT'S VESSEL. IT WAS ALSO NOTED THAT AS PER PHYSICIAN SUBJECT COIL KEPT GOING OUT OF THE ANEURYSM, AND THIS WAS BECAUSE OF THE ANEURYSM'S MORPHOLOGY. THE OPERATOR KEPT TRYING TO PUSH AND PULL THE COIL IN & OUT OF THE STENT, AND SUDDENLY IT WAS DETACHED WITHOUT ANY DETACHMENT DEVICE CONNECTED. AS, THE SUBJECT COIL WAS STUCK AT THE TIP OF THE MICROCATHETER, THEY COULD EASILY REMOVE THE COIL FROM THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066300 ↗
• MalfunctionJan 17, 2023Premature Separation; Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL HAD PREMATURELY DETACHED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16184001 ↗
• MalfunctionSep 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT COIL WAS BROKEN DURING USE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12514453 ↗
• MalfunctionJan 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL BROKE OFF WHILE THE PHYSICIAN WAS RETRACTING IT INTO THE MICRO CATHETER. THE BROKEN COIL WAS RETRIEVED USING A GUIDE WIRE THROUGH 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 11135616 ↗
• InjuryDec 28, 2020Migration; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT FIRST COIL WAS DETACHED IN THE ANEURYSM; HOWEVER, WHEN THE PHYSICIAN INSERTED A SECOND COIL, IT WAS NOT ABLE TO ADVANCE THE COIL OUT OF THE MICROCATHETER SINCE TO THE PROXIMAL END OF THE FIRST MAIN COIL WAS STUCK INSIDE THE CATHETER TIP. WHEN THE PHYSICIAN TRIED TO PULL BACK THE CATHETER, THE CATHETER DRAGGED THE FIRST COIL BACK IN THE VESSEL. A STENT WAS DEPLOYED IN THE SUPRACLINOID INTERNAL CAROTID ARTERY (ICA) TO HELD DOWN THE COIL TAIL IN THE VESSEL. 90 MINUTES OF SURGICAL DELAY WAS REPORTED. THE PATIENT WAS NOT AFFECTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11074676 ↗
• MalfunctionNov 24, 2020Activation, Positioning or Separation Problem

  THE TARGET COIL DIDN'T DEPLOY OUT OF THE CASING; IT DID NOT PUSH OUT OF THE SHEATH. IT DID NOT COME IN CONTACT WITH THE PATIENT. MANUFACTURER RESPONSE FOR DEVICE, NEUROVASCULAR EMBOLIZATION, TARGET (PER SITE REPORTER). THEY SENT A (B)(6) LABEL TO RETURN THE DEVICE TO THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10894160 ↗
• MalfunctionJul 30, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL (TARGET) PREMATURELY DETACHED IN THE CATHETER DURING THE PROCEDURE. THE PATIENTS¿ MEDICAL CONDITION WAS GOOD. THERE WERE NO ADVERSE CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347197 ↗
• MalfunctionNov 21, 2019Fracture; Premature Separation; Fracture; Premature Separation

  IT WAS REPORTED THAT THE COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER AND POSSIBLY FRACTURED FROM THE ANEURYSM. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9360162 ↗