TARGET M0036181650Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327128352), received between May 18, 2018 and Sep 3, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 18, 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.

• MalfunctionSep 3, 2026Migration

  It was reported that during procedure, the microcatheter was withdrawn at the conclusion of the procedure; however, the subject coil was inadvertently pulled out together with the microcatheter.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 50577640 ↗
• MalfunctionJan 3, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION PROCEDURE THE SUBJECT COIL SPONTANEOUSLY DETACHED. 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 18436673 ↗
• MalfunctionJan 30, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED FROM THE DELIVERY WIRE IN THE INTERNAL CAROTID ARTERY (ICA) WHILE BEING DEPLOYED. THE DELIVERY WIRE WAS REMOVED FROM THE PATIENTS BODY. THE COIL WAS NOT FULLY DEPLOYED IN THE ANEURYSM SO THE PHYSICIAN USED A STENT TO TACK DOWN THE COIL TAIL TO KEEP IT IN PLACE AND TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16268569 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL INSERTION WITH CONSIDERABLE SPEED IN AND OUT CAUSED THE COIL (SUBJECT DEVICE) TO STRETCH AT DISTAL. AFTER THAT, SUBSEQUENT ATTEMPTS WERE MADE TO RETRIEVE THE COIL (SUBJECT DEVICE); HOWEVER, IT WAS DIFFICULT. A SNARE AND FORCEPS TYPE WAS USED TO RETRIEVE THE COIL (SUBJECT DEVICE). EVENTUALLY, IT WAS RETRIEVED WITHOUT REMAINING IN THE BODY, BUT A THROMBUS WAS CONFIRMED IN THE INGUINAL REGION. THE CAUSAL RELATIONSHIP BETWEEN THE COIL (SUBJECT DEVICE) AND THE THROMBUS WAS UNKNOWN. THE PATIENT WAS RE-TREATED AT A LATER DATE. THE THROMBUS WAS SUCCESSFULLY TREATED AND THE RE-TREATMENT WAS COMPLETED. THERE WAS A SURGICAL DELAY FOR FOUR HOURS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14379962 ↗
• MalfunctionMay 7, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING EMBOLIZATION OF TYPE I ENDOLEAK AFTER TEVER, THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED DURING PLACEMENT. THE DETACHED COIL (SUBJECT DEVICE) WAS PUSHED INTO THE MASS BY THE DELIVERY WIRE AND PLACED. 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 14318139 ↗
• MalfunctionMay 18, 2018Break; Break

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE FIRST COIL DETACHED IN THE MICROCATHETER INSIDE THE PATIENT. THE CUSTOMER DID NOT MAINTAIN CONTINUOUS FLUSH AS RECOMMENDED PER DFU. THE PHYSICIAN DID NOT MAKE ANY ATTEMPTS TO DETACH THE COIL USING THE DETACHMENT SYSTEM. THE PHYSICIAN REMOVED THE DETACHED COIL TO CONTINUE WITH THE PROCEDURE. A SNARE DEVICE WAS NOT USED WHEN THE SUBJECT COIL WAS REMOVED. SIMILAR EVENT OCCURRED TO ANOTHER COIL (THE SECOND REPORTED SUBJECT DEVICE) USED IN THE PROCEDURE. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7527752 ↗