TARGET M0035431520Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540698032), received between Jul 8, 2016 and Aug 4, 2021 — 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. 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.

• MalfunctionAug 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN FACED DIFFICULTY IN PULLING THE SUBJECT COIL OUT OF THE MICROCATHETER AND IT GOT DISINTEGRATED AND THE DELIVERY WIRE OF THE SUBJECT COIL WAS KINKED. THE DEVICE WAS RETURNED FOR ANALYSIS AND INVESTIGATION OF THE DEVICE REVEALED THAT THE DELIVERY WIRE OF THE SUBJECT COIL WAS FRACTURED/BROKEN DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276021 ↗
• MalfunctionDec 2, 2020Fracture; Fracture

  IT WAS REPORTED DURING A PROCEDURE FOR A MCA (MIDDLE CEREBRAL ARTERY) WIDE-NECKED ANEURYSM SIZED 3.4MM*4.3MM, PHYSICIAN DELIVERED MICROCATHETERS UNDER GUIDING OF GUIDEWIRE TO RIGHT MCA M2 SEGMENT. PHYSICIAN THEN USED COILS TO BEGIN FILLING ANEURYSM. DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) SHOWED THE ANEURYSM WAS PARTIALLY EMBOLIZED AND PHYSICIAN THEN PROCEEDED TO DELIVER STENT TO COVER NECK OF ANEURYSM. UPON FILLING WITH SUBJECT COIL, BIG RESISTANCE WAS ENCOUNTERED AND COULD NOT BE DELIVERED OUT OF MICROCATHETER. PHYSICIAN PROCEEDED TO REMOVE SUBJECT AND NOTED THAT THE COIL HAD BROKEN AND THE TAIL WAS STRETCHED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUBJECT COIL WAS NOT BROKEN/FRACTURED DURING USE; THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED NON-REPORTABLE WITH THE NEW AWARENESS DATE OF 30-DEC-2020. THE PI WILL BE RE ASSESSED TO REFLECT THE DECISION CHANGE AND EMDR WILL BE FILED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10932563 ↗
• MalfunctionApr 9, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS NOTED TO BE STRETCHED AND HAD PREMATURELY DETACHED DURING USE. THE SUBJECT DEVICE WAS REMOVED. THE PHYSICIAN REPLACED WITH ANOTHER OF THE SAME DEVICE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS STABLE AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUBJECT COIL WAS NOT PREMATURELY DETACHED AS THE COIL WAS STILL INTACT THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED NON-REPORTABLE WITH THE NEW AWARENESS DATE OF 27-JUL-2020. THE EVENT WILL BE RE ASSESSED TO REFLECT THE DECISION CHANGE AND EMDR WILL BE FILED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9942112 ↗
• InjuryAug 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM LOCATED ON THE INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (IC-PC), THERE WAS DIFFICULTY RE-POSITIONING THE 7TH COIL (SUBJECT DEVICE) IN THE ANEURYSM. AFTER THREE ATTEMPTS, THE SUBJECT COIL WAS STUCK AND COULD NOT BE MOVED WHEN RETRIEVING A LITTLE THE MICROCATHETER. A BALLOON CATHETER WAS INFLATED AT THE NECK OF THE ANEURYSM TO HOLD THE IMPLANTED COILS IN ANEURYSM SO THAT THE SUBJECT COIL COULD BE RETRIEVED WITH THE MICROCATHETER. THE PHYSICIAN CONFIRMED AFTER PROCEDURE THAT THE TIP OF THE MICROCATHETER WAS DEFORMED. THE SUBJECT COIL WAS MECHANICAL DETACHED AFTER REMOVAL FROM THE PATIENT ¿S BODY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8881247 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER COIL (SUBJECT DEVICE) IMPLANTATION,THE THROMBOSIS WAS OCCURED IN THE P-COM (POSTERIOR COMMUNICATING ARTERY) AND IT WAS RESOLVED BY THROMBECTOMY USING A STENT RETRIEVER. NO FURTHER DETAILS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 7615069 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE EMBOLIZATION PROCEDURE FOR THE ANEURYSM WITH THE STATUS OF SAH (SUBARACHNOID HEMORRHAGE) AT A-COM ARTERY, IT WAS REPORTED THAT THE SUBJECT COIL WAS IMPLANTED AND THEN THE INTRAOPERATIVE RUPTURE OCCURRED. THE RUPTURE WAS RESOLVED BY IMPLANTING ADDITIONAL COILS AND THE PATIENT RECOVERED.

  Patient problems: Aneurysm; Rupture

  MAUDE report 7612385 ↗
• MalfunctionJul 8, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE COIL WAS PLACED INTO THE ANEURYSM AND DETACHMENT WAS ATTEMPTED. THE COIL DID NOT DETACH AND THE PHYSICIAN STARTED TO WITHDRAW THE PUSHER WIRE UNDER FLUOROSCOPY; HOWEVER, THE COIL SPONTANEOUSLY DETACHED WHILE WITHDRAWING THE PUSHER WIRE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5779094 ↗