TARGET M0035478300Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540676603), received between Sep 8, 2018 and Oct 17, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS REVEALED THAT THE MAIN COIL (SUBJECT DEVICE) AND COIL DELIVERY WIRE (SUBJECT DEVICE) WERE BROKEN/FRACTURED 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 23330729 ↗
• MalfunctionMar 12, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DETACHED WITHOUT USING A POWER SUPPLY AND THE SUBJECT COIL WAS STRETCHED. THE SUBJECT COIL WAS REMOVED, 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 18887253 ↗
• MalfunctionDec 15, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DETACHED PREMATURELY WHEN ONLY TWO LOOPS WERE IN THE ANEURYSM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336971 ↗
• MalfunctionApr 26, 2023Premature Separation; Premature Separation

  IT WAS REPORTED DURING COILING PROCEDURE, THE SUBJECT COIL WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER . THE MICROCATHETER WAS COMPLETELY REMOVED FROM THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820893 ↗
• InjuryJul 11, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE TREATMENT OF POSTERIOR CEREBRAL ARTERY ANEURYSM THE SUBJECT COIL PREMATURELY DETACHED IN THE CATHETER AND WAS REMOVED USING A SNARE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981957 ↗
• MalfunctionJun 28, 2022Premature Separation; Premature Separation

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL(SUBJECT DEVICE) PREMATURELY DETACHED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841984 ↗
• InjuryMar 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS STRETCHED AT THE DISTAL PART UPON DEPLOYMENT, AND IT COULD NOT BE ADVANCE OR RETRIEVED INSIDE THE MICROCATHETER. THE PHYSICIAN APPLIED FORCE TO REMOVE THE COIL (SUBJECT DEVICE) BUT THE MAIN COIL WAS FRACTURED AND WAS LEFT INSIDE THE ANATOMY. A SNARE WAS USED TO RETRIEVE THE FRAGMENT BUT REMOVAL WAS NOT SUCCESSFUL. THERE WAS A 40 MINS DELAY DURING THE PROCEDURE TO REMOVE THE COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13831778 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Premature Separation; Adverse Event Without Identified Device or Use Problem; Premature Separation

  IT WAS REPORTED THAT DURING POSTERIOR COMMUNICATING ARTERY (PCOMA) ANEURYSM PROCEDURE, THE PHYSICIAN PLACED A GUIDE CATHETER, GUIDEWIRE AND MICROCATHETER TO BUILD ACCESS TO THE ANEURYSM AND DEPLOYED A STENT. THEN PREPARED TO FRAME THE SUBJECT COIL TO THE TREATMENT SITE. PHYSICIAN FELT FRICTION WHILE ADVANCING THE SUBJECT COIL IN THE DISTAL OF THE MICROCATHETER AND THE SUBJECT COIL WAS DEPLOYED PREMATURELY INSIDE THE MICROCATHETER. A SNARE DEVICE WAS USED TO RETRIEVE THE SUBJECT COIL. THE PHYSICIAN REPLACED IT WITH A SAME NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12742494 ↗
• MalfunctionJun 10, 2019Premature Separation; Premature Separation

  ANALYSIS OF THE DEVICE REVEALED THAT THE SUBJECT COIL PREMATURELY DETACHED INSIDE PATIENT. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8684354 ↗
• MalfunctionDec 29, 2018Break; Break

  DURING THE STENT ASSISTING COIL EMBOLIZATION PROCEDURE FOR AN ANEURYSM, IT WAS REPORTED THAT BIG RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE 9TH COIL IN THE MICROCATHETER. SO THE PHYSICIAN WITHDRAW THE COIL AND FOUND IT WAS STRETCHED AND FRACTURED. THEN THE WHOLE COIL WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER CHANGING TO ANOTHER COIL. THE PATIENT¿S CONDITION WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8205262 ↗
• InjurySep 8, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AVF (ARTERIOVENOUS FISTULA) SIGMOID SINUS PROCEDURE, THE SUBJECT DEVICE (COIL) WAS STUCK INSIDE THE COIL MASS. THE SUBJECT DEVICE WAS WITHDRAWN CAREFULLY BUT IT WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER. SINCE THE SUBJECT DEVICE WAS TANGLED WITH THE COIL MASS, THE SUBJECT DEVICE WAS RETRIEVED AND SAFELY REMOVED FROM THE PATIENT BY USING SNARE DEVICE. THE PROCEDURE WAS FINISHED WITHOUT ADDITIONAL COIL. THE PATIENT¿S CURRENT CONDITION IS FINE.NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7858444 ↗