Target M0035432060Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540676016), received between Mar 23, 2017 and Jan 10, 2022 — classified as 4 injuries, 4 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13209525 ↗
• InjuryOct 13, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ACOMA ANEURYSM EMBOLIZATION, PHYSICIAN DELIVERED FOUR COILS INTO THE ANEURYSM WITH THE HELP OF A MICROCATHETER. WHEN PREPARED TO USE THE SUBJECT COIL TO FINISH THE PROCEDURE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE SUBJECT COIL OUT OF THE INTRODUCING SHEATH. AFTER SEVERAL TRIES, THE SUBJECT COIL WAS DELIVERED INTO THE MICROCATHETER. THE SUBJECT COIL WAS ADVANCED WITH RESISTANCE INSIDE THE MICROCATHETER. WHILE DELIVERING THE SUBJECT COIL INTO THE ANEURYSM IT GOT STUCK INSIDE THE MICROCATHETER AND COULD NOT BE ADVANCED. WHEN THE PHYSICIAN TRIED TO WITHDRAW THE SUBJECT COIL IT PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN USED A MICRO GUIDEWIRE TO REMOVE THE SUBJECT COIL OUT OF THE PATIENT ANATOMY AND THE DISTAL PART OF THE SUBJECT COIL WAS FOUND STRETCHED. THE PHYSICIAN DECIDED TO FINISH THE PROCEDURE DIRECTLY BASED ON THE PREVIOUS EFFECT OF THE EMBOLIZATION. 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 12623092 ↗
• MalfunctionFeb 4, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED INSIDE THE MICRO CATHETER DURING PROCEDURE. THE PHYSICIAN REMOVED THE SUBJECT COIL ALONG WITH THE MICRO CATHETER FROM THE PATIENT'S ANATOMY, REPLACED THE COIL AND USED THE SAME MICRO CATHETER AGAIN TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9663236 ↗
• InjuryJul 31, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT COIL THROUGH THE MICROCATHETER AND THE COIL WAS MECHANICALLY DETACHED INSIDE THE MICROCATHETER SHAFT. THE BROKEN PART OF THE COIL WAS REMOVED BY APPLYING NEGATIVE PRESSURE WITH SYRINGE. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8847302 ↗
• InjuryJun 26, 2019Material Protrusion/Extrusion; Premature Separation; Material Protrusion/Extrusion; Premature Separation

  IT WAS REPORTED THAT WHEN THE COIL (SUBJECT DEVICE) WAS NOT DEPLOYED DURING BAE (BASILAR ARTERY EMBOLIZATION) WAS DONE FOR THE SUPERIOR THORACIC ARTERY AND THE RESISTANCE WAS FELT. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL (SUBJECT DEVICE) BY USING THE MICROCATHETER (STRYKER) BUT THE COIL WAS NOT MOVED, AND THE STRETCH OF THE COIL WAS CONFIRMED UNDER FLUOROSCOPY. THE RESISTANCE WAS FELT AT SHEATH PART. THEREFORE; THE GUIDING CATHETER (NON-STRYKER) WAS USED TO RETRIEVE THE COIL ALONG WITH THE MICROCATHETER. UPON REMOVAL, THE COIL HAD DETACHED IN THE MICROCATHETER BY FLUOROSCOPY, AND THE COIL COULD NOT BE CONFIRMED AT OUT OF THE BODY. AFTER RETRIEVING THE COIL, IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE PROXIMAL OF THE COIL WAS PROTRUDE FROM THE COIL MASS . NO FURTHER INFORMATION IS AVAILABLE. UPDATE PATIENT INFORMATION : RECEIVED ADDITIONAL INFORMATION STATED THAT THE PATIENT¿S CURRENT CONDITION IS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8737657 ↗
• MalfunctionJul 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE, A FALSE DETACHMENT OCCURRED AND THE COIL CAME 2CM OUT OF THE VESSEL WITH THE DELIVERY WIRE. SOME PART OF THE COIL WAS LEFT HANGING IN THE VESSEL. NO ADDITIONAL PROCEDURE WAS PERFORMED. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720256 ↗
• MalfunctionNov 30, 2017Break; Break

  DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE MAIN COIL WAS BROKEN. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7071269 ↗
• InjuryMar 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF ANEURYSM THERE WAS A THROMBUS PRESENT ON THE COIL DETACHMENT ZONE OF THE COIL. MULTIPLE ATTEMPTS WERE MADE TO PUT THE FIRST COIL AND THEN SECOND COIL (SUBJECT COIL) IN THE ANEURYSM WITHOUT SUCCESS. BOTH THE COILS WERE REMOVED AND PROCEDURE WAS COMPLETED WITH A THIRD OF THE SAME DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: Thrombus

  MAUDE report 6430281 ↗