TARGET M0035466300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613252239444), received between Jun 29, 2016 and Nov 19, 2024 — classified as 3 injuries, 4 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING POSTERIOR INFERIOR CEREBELLAR ARTERY PROCEDURE, WHEN DELIVERING THE SUBJECT COIL IN THE MICROCATHETER, THE RESISTANCE WAS ENCOUNTERED, AND THE SUBJECT COIL WAS BROKEN. PART OF THE STRAND OF THE SUBJECT COIL WAS LEFT INSIDE THE PATIENT AND REQUIRED ENDOVASCULAR COILING INTERVENTION AND CAUSED 35 MINUTES SURGICAL DELAY. POST PROCEDURE, THE PATIENT IS MODERATELY ACTIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20730260 ↗
• MalfunctionDec 20, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE SUBJECT COIL DROPPED BY ITSELF. EMBOLIZATION PROCEDURE WAS CONTINUED BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13049718 ↗
• MalfunctionMar 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR INTERVENTION ON A RUPTURED ANEURYSM, THE SUBJECT COIL BROKE UNEXPECTEDLY INSIDE THE MICROCATHETER. THERE WAS SURGICAL DELAY OF UNKNOWN LENGTH REPORTED DURING THE PROCEDURE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530188 ↗
• MalfunctionOct 12, 2020Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10660427 ↗
• InjuryAug 16, 2018Premature Separation; Premature Separation

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE MAIN COIL PREMATURELY DETACHED OUTSIDE THE ANEURYSM AND THE MAIN COIL WAS LEFT IN THE PATIENT. THERE WAS A SLIGHT DELAY TO THE SURGICAL AND THE ASPIRIN WAS PROVIDED TO THE PATIENT AS A RESULT OF THE REPORTED EVENT. NO FURTHER INFORMATION IS AVAILABLE NOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7791902 ↗
• MalfunctionOct 13, 2016Premature Activation; Premature Activation

  ANALYSIS OF THE INVESTIGATION RESULTS REVEALED THAT THE MAIN COIL PREMATURELY DETACHED/SEPARATED INSIDE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6029130 ↗
• InjuryJun 29, 2016Migration or Expulsion of Device; Premature Activation; Migration or Expulsion of Device; Premature Activation

  IT WAS REPORTED THAT DURING THE COIL PLACEMENT INTO A GIANT INTERNAL CAROTID ANEURYSM, WHILE THE BIGGEST PART OF THE COIL WAS ALREADY INSIDE THE ANEURYSM, THE COIL PREMATURELY DETACHED WITHOUT USING OF DETACHMENT DEVICE. THE BIG PART OF THE COIL STAYED INSIDE THE ANEURYSM BUT THE SMALL PART OF THE COIL PROTRUDED INTO THE PARENT VESSEL. THE WHOLE COIL WAS SUCCESSFULLY REMOVED USING A SNARE RETRIEVAL DEVICE. ANOTHER OF THE SAME COIL WAS UNEVENTFULLY IMPLANTED INTO THE ANEURYSM. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5760433 ↗