TARGET M0036180840Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327466423), received between Dec 18, 2019 and Feb 15, 2026 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2026Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL SUDDENLY BECAME VERY STIFF IN THE MIDWAY AND COULDN¿T BE PUSHED AT ALL. THE PHYSICIAN ATTEMPTED TO GRASP THE SUBJECT COIL DELIVERY WIRE WITH A GAUZE AND ADVANCE IT FURTHER, BUT IT WAS TOO STIFF TO PUSH FORWARD. AFTER REPEATED PUSHING AND PULLING FOR A WHILE, THE PHYSICIAN ATTEMPTED TO LEAVE THE SUBJECT COIL IN PLACE, BUT AN EARLY DETACHMENT OCCURRED. THE SUBJECT COIL REMAINED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN FLUSHED THE MICROCATHETER WITH A SYRINGE AND LEFT THE SUBJECT COIL IN PLACE. 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 24341621 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SUBJECT COIL EMBOLIZATION PROCEDURE OF LEFT SMA (SUPERIOR MESENTERIC ARTERY), THE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE SUBJECT COIL WITHIN THE MICROCATHETER SHAFT. THE SUBJECT COIL WAS ONCE RETRACTED AND WHEN IT WAS SOAKED IN THE SALINE SOLUTION, THROMBUS WAS FOUND ON THE DISTAL TIP OF THE SUBJECT COIL. THE LUMEN OF THE MICROCATHETER WAS FLUSHED, AND THE SUBJECT COIL WAS REINSERTED; HOWEVER, RESISTANCE WAS ENCOUNTERED IN THE SHAFT AGAIN. THEREFORE, THE SUBJECT COIL WAS RETRIEVED AND REPLACED WITH ANOTHER COIL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME MICROCATHETER.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24240672 ↗
• MalfunctionJun 3, 2025Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL DELIVERY WIRE WAS 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 22137283 ↗
• InjuryApr 9, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE EMBOLIZATION PROCEDURE, THE SUBJECT COIL WAS DETACHED WHILE ADVANCING INSIDE THE CATHETER. THE DETACHED COIL WAS REMOVED USING THE GUIDEWIRE. WHILE REMOVING THE SUBJECT COIL, ANOTHER COIL THAT WAS ALREADY IMPLANTED, CAME OUT WITH THE DETACHED COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21809813 ↗
• MalfunctionJul 17, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING HEPATIC ARTERY COIL EMBOLIZATION PROCEDURE THE SUBJECT COIL WAS REPOSITIONED TWICE, AFTER WHICH IT PREMATURELY DETACHED INSIDE THE MICROCATHETER. NEGATIVE PRESSURE WAS APPLIED TO RETRIEVE THE SUBJECT COIL FROM THE MICROCATHETER. 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 19767731 ↗
• MalfunctionMay 7, 2024Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE COIL (SUBJECT DEVICE) WAS DETACHED/SEPARATED DURING USE. 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 19261228 ↗
• MalfunctionDec 18, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE SUBJECT COIL GOT STUCK INSIDE THE MICROCATHETER. WHEN TRIED TO RETRIEVE THE SUBJECT COIL WITH A WIRE, IT GOT PRE-MATURELY DETACHED INSIDE THE MICROCATHETER. THE SUBJECT COIL WAS REMOVED ALONG WITH THE MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18342769 ↗
• MalfunctionOct 5, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A RENAL ARTERY PSEUDOANEURYSM BLEEDING, THE SUBJECT COIL WAS ADVANCED INTO THE MICROCATHETER. HOWEVER, THE SUBJECT COIL GOT STUCK AND THE OPERATOR REMOVED IT. AFTER THE WITHDRAWAL IT WAS FOUND THAT THE COIL PREMATURELY 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 17883255 ↗
• MalfunctionOct 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, WHEN THE SUBJECT COIL WAS ADVANCED THROUGH A NON STRYKER MICROCATHETER WITH INTERMITTENT FLUSH, THE RESISTANCE WAS TOO STRONG IN THE SHAFT TO BE ADVANCED. WHEN THE SUBJECT COIL WAS RETRIEVING FROM THE MICROCATHETER, IT GOT FRACTURED AT THE COIL JUNCTION WITHIN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17872935 ↗
• MalfunctionJul 24, 2023Premature Separation; Premature Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376241 ↗
• MalfunctionNov 21, 2022Fracture; Fracture

  ANALYSIS OF RETURNED DEVICE REVEALED THAT SUBJECT MAIN COIL WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15840968 ↗
• MalfunctionNov 4, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED WITHIN THE MICROCATHETER. 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 15740706 ↗
• MalfunctionOct 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A PSEUDOANEURYSM FROM THE PROPER HEPATIC ARTERY TO THE CELIAC ARTERY, THE SURGEON PERFORMED EMBOLIZATION OF BOTH THE MAIN VESSEL AND THE ANEURYSM. THE FIRST COIL HE SELECTED ENCOUNTERED RESISTANCE WHEN GUIDING IT FROM THE INTRODUCER SHEATH TO THE HUB USING NON-STRYKER CATHETER. THEN, THE SURGEON USED THE SUBJECT COIL BUT, HE COULD NOT PROCEED DUE TO STRONG RESISTANCE FELT AT THE TIP OF THE CATHETER. AFTER COLLECTING THE SUBJECT COIL, HE CHECKED IT AND FOUND THAT IT WAS BROKEN/FRACTURED. THE SURGEON REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619068 ↗
• MalfunctionApr 20, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE OF SPLEEN ANEURYSM COIL EMBOLIZATION, WHEN THE SUBJECT COIL WAS ATTEMPTED TO ADVANCED INTO THE MICROCATHETER, THERE WAS RESISTANCE INSIDE THE MICROCATHETER AND IT GOT DETACHED PREMATURELY. THE PREMATURELY DETACHED SUBJECT COIL WAS REMOVED FROM THE PATIENT'S VASCULATURE BY APPLYING NEGATIVE PRESSURE WITH A SYRINGE. THE PHYSICIAN REPLACED THE SUBJECT COIL WITH A NEW DEVICE AND SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697789 ↗
• MalfunctionDec 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN THE COIL (SUBJECT DEVICE) WAS ADVANCED INTO THE CATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE COIL AND IT WAS FOUND BROKEN IN CATHETER. THE COIL WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9490227 ↗