TARGET M0035477300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540676580), received between Apr 26, 2018 and Oct 23, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Fracture; Fracture

  DURING AN ANEURYSM PROCEDURE, THE PHYSICIAN USED THE SUBJECT COIL TO EMBOLIZE THE ANEURYSM. AFTER PART OF THE SUBJECT COIL WAS PUSHED INTO THE ANEURYSM SAC, THE PHYSICIAN DEEMED THE POSITION OF THE FRAMING COIL WITHIN THE SAC UNSATISFACTORY AND INTENDED TO ADJUST THE ANGLE. WHILE WITHDRAWING THE SUBJECT COIL, THE CONNECTION BETWEEN THE SUBJECT COIL AND THE DELIVERY WIRE RUPTURED, CAUSING THE DELIVERY WIRE TO SEPARATE FROM THE SUBJECT COIL, WITH ONLY THE ANTI-STRETCH WIRE REMAINING CONNECTED. THE PHYSICIAN SLOWLY RETRACTED THE SUBJECT COIL, WITH PART OF IT RETRACTING INTO THE MICROCATHETER AND PART REMAINING IN THE BLOOD VESSEL AND ANEURYSM. THEREFORE, THE PHYSICIAN CAREFULLY WITHDREW THE MICROCATHETER TO BRING THE RUPTURED SUBJECT COIL OUT OF THE BODY. WHEN PULLING THE COIL OUT TO THE RHV POSITION, THE ANTI-STRETCH WIRE CONNECTING THE SUBJECT COIL AND THE DELIVERY WIRE COMPLETELY RUPTURED. A NEW COIL WAS REPLACED, AND THE SURGERY WAS COMPLETED WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372649 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL WAS STRETCHED AND THE MEDICAL INTERVENTION WAS PERFORMED TO RECOVER THE STRETCHED COIL AND THE ANTI-FIBRINOLYTICS WAS ADMINISTERED TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 16092043 ↗
• InjuryDec 23, 2022Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION PROCEDURE, THE SUBJECT COIL STRETCHED WHILE DEPLOYING INSIDE THE TARGET LESION. PHYSICIAN WAS UNABLE TO REMOVE THE SUBJECT COIL FROM THE PATIENT ANATOMY. ADDITIONAL MEDICATION WAS GIVEN TO THE PATIENT DUE TO THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON 17-JAN-2023, CLARIFIED THAT THE SUBJECT COIL WAS ALSO PROTRUDING FROM THE ANEURYSM TO THE ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16043078 ↗
• MalfunctionMar 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT COIL WAS FRACTURED WHEN ADVANCED THROUGH THE MICROCATHETER SHAFT. THE COIL AND MICROCATHETER WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559280 ↗
• MalfunctionNov 4, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN WAS UNABLE TO ADVANCE THE COIL INTO THE ANEURYSM. SO HE DECIDE TO WITHDREW THE SUBJECT COIL AND WHILE DOING SO IT DETACHED PREMATURELY INSIDE THE MICRO CATHETER. 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 10786159 ↗
• MalfunctionJan 29, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION RETREATMENT, ANGIOGRAPHY REVEALED THAT THE 3RD COIL (SUBJECT DEVICE) WAS HERNIATED OUT OF THE ANEURYSM NECK. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286298 ↗
• InjuryApr 26, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT DIFFICULTY WAS ENCOUNTERED WHEN THE DELIVERY WIRE OF THE SECOND COIL WAS INSERTED INTO THE DETACHMENT SYSTEM AND THE PROXIMAL CONTACT WAS BENT. THEN THE PHYSICIAN TRIED TO DETACH THE COIL, HOWEVER EVEN THOUGH LONG BEEP WAS SOUNDED TWICE THE COIL COULD NOT BE DETACHED. SO THE PHYSICIAN REMOVED THE DELIVERY WIRE FROM THE DETACHMENT SYSTEM AND REINSERTED AGAIN, BUT THE DETACHMENT SYSTEM DID NOT POWER ON. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE COIL. AFTER REMOVAL THE PROXIMAL PART OF THE DELIVERY WIRE FROM THE DETACHMENT SYSTEM, THE PHYSICIAN CONFIRMED THAT THE ANODE OF THE PROXIMAL CONTACT WAS EXPOSED. IN ADDITION, WHEN THE PHYSICIAN TRIED TO REMOVE THE SECOND COIL FROM THE PATIENT, IT WAS FOUND THAT THE SECOND COIL WAS TANGLED WITH THE FIRST COIL (SUBJECT DEVICE) WHICH WAS INITIALLY SUCCESSFULLY IMPLANTED IN THE ANEURYSM. HENCE BOTH COILS WERE RETRIEVED WITH SNARE. THE PROCEDURE WAS COMPLETED WITH OTHER COILS. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7467317 ↗