Target M0035432080Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540676023), received between Aug 24, 2016 and Nov 21, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Premature Separation; Premature Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618107 ↗
• MalfunctionFeb 7, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS REPOSITIONED SEVERAL TIMES WITHIN THE SHAFT OF MICROCATHETER, THE COIL NO LONGER MOVED AS INTENDED AND BECAME STRETCHED. OPERATOR REMOVED THE COIL WITH THE ENTIRE MICROCATHETER AND REPLACED WITH A NEW DEVICE AND COMPLETED THE PROCEDURE SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21338325 ↗
• MalfunctionJun 29, 2022Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) WAS BROKEN AND FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852482 ↗
• MalfunctionFeb 5, 2021Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL PREMATURELY DETACHED/SEPARATED DURING THE PROCEDURE. 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 11283816 ↗
• MalfunctionMar 23, 2020Separation Failure; Premature Separation; Separation Failure; Premature Separation

  IT WAS REPORTED THAT AFTER THE COIL (SUBJECT DEVICE ) WAS PLACED INSIDE THE ANEURYSM, IT WAS ATTEMPTED TO BE DETACHED 5 TIMES WITHOUT SUCCESS. DURING RETRACTION OF THE COIL DELIVERY WIRE, THE SUBJECT COIL PREMATURELY DETACHED, PLACED INSIDE THE PARENT ARTERY, AND WAS MANAGED TO BE PLACED BACK AT THE TARGET SITE BY PUSHING WITH THE MICROCATHETER AND GUIDEWIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865530 ↗
• MalfunctionNov 1, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE SUBJECT COIL WAS ATTEMPTED TO INSERT FOR BRONCHIAL ARTERY EMBOLIZATION, THE RESISTANCE WAS ENCOUNTERED FROM THE MIDDLE OF THE MICROCATHETER AND THE SUBJECT COIL WAS PREMATURELY DETACHED IN THE TARGET ARTERY. THE TAIL PART OF THE SUBJECT COIL WAS REMAINED INSIDE THE MICROCATHETER; THEREFORE; A FLUSH WITH SALINE WAS GIVEN TO PUSH THE REMAINING SUBJECT COIL INTO THE TARGET ARTERY AND THE TAIL OF THE SUBJECT COIL WAS SUCCESSFULLY PLACED INSIDE TARGET ARTERY. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269234 ↗
• MalfunctionJun 7, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT A TOTAL OF 11 COILS WERE USED FOR COLLATERAL CIRCULATION EMBOLISM PROCEDURE. DURING PROCEDURE, THE SUBJECT COIL COULD NOT BE ADVANCED, AND IT WAS PREMATURELY DETACHED SEVERAL CENTIMETERS FROM THE HUB DUE TO THE RESISTANCE IN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH OTHER COILS WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8680183 ↗
• InjuryMar 27, 2019Material Protrusion/Extrusion; Premature Separation; Material Protrusion/Extrusion; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE FOR AN ANEURYSM, THE COIL (SUBJECT DEVICE) WAS REPOSITIONED SEVERAL TIMES AND PREMATURELY DETACHED. THE PROCEDURE WAS ENDED WITH THE COIL PROTRUDING FROM THE PARENT VESSEL. THE PHYSICIAN USED THE MICROCATHETER TO PUSH THE COIL INSIDE AND THE PATIENT WAS GIVEN ANTIPLATELETS TO PREVENT CLOTTING AROUND THE PRE-DETACHED COIL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8458549 ↗
• MalfunctionOct 18, 2018Break; Break

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7981111 ↗
• MalfunctionNov 18, 2016Premature Activation; Premature Activation

  ANALYSIS OF THE DEVICE REVEALED THAT THE MAIN COIL DETACHED FROM THE DELIVERY DUE TO A PHYSICAL BREAK AT THE DETACHMENT ZONE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6112614 ↗
• MalfunctionAug 24, 2016Break; Break

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE COIL DELIVERY WIRE WAS BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5900885 ↗