TARGET XL M0036122030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327128321), received between Jan 6, 2021 and May 2, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS GUIDED INTO THE PATIENT ANATOMY. PHYSICIAN FELT RESISTANCE WHILE REPOSITIONING THE SUBJECT COIL TO ENGAGE TO THE VESSEL. AFTER CONFIRMING THAT THE SUBJECT COIL HAD SETTLED WITHIN THE TARGET LESION, PHYSICIAN STARTED TO DETACH THE SUBJECT COIL AND SLOWLY PULLED THE DELIVERY WIRE AND IT WAS FOUND THAT THE SUBJECT COIL WAS STRETCHED. A SNARE DEVICE WAS USED TO RETRIEVE THE SUBJECT COIL FROM THE PATIENT ANATOMY. 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 16856987 ↗
• MalfunctionJan 28, 2022Inadequate User Interface; Inadequate User Interface

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE PHYSICIAN WAS REPEATEDLY INSERTING AND REMOVING THE SUBJECT COIL IN AND OUT OF THE MICROCATHETER TO PLACE TO THE TARGET AREA, THE MIDDLE PART OF THE COIL SUBJECT DEVICE WAS NOT VISIBLE AND ON RETRIEVAL THE SUBJECT COIL WAS FOUND STRETCHED. 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 13387370 ↗
• MalfunctionSep 16, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) ENCOUNTERED RESISTANCE IN THE HUB OF MICROCATHETER, WHILE THE SUBJECT COIL WAS ADVANCING THE INTRODUCER SHEATH, AND WHEN ADVANCING THE SUBJECT COIL IN THE MICROCATHETER. WHEN CHECKED THROUGH FLUOROSCOPY, THE SUBJECT COIL DIDN'T MOVE EVEN IF THE DELIVERY WIRE WAS PUSHED. WHEN THE DELIVERY WIRE WAS RETRACTED BECAUSE THERE WAS A FEELING THAT SOMETHING WAS WRONG, THE SUBJECT COIL DID NOT COME ALONG WITH THE DELIVERY WIRE, AND WHEN IT WAS REMOVED TOGETHER WITH THE ENTIRE MICROCATHETER AND CHECKED IT, THE SUBJECT COIL WAS PREMATURELY DETACHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT BY REPLACING THE SUBJECT COIL WITH SAME PRODUCT . USED THE SAME NON-STRYKER MICROCATHETER. THERE WAS NO REMAIN SUBJECT COIL IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485632 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, WHILE REPOSITIONING THE SUBJECT COIL SEVERAL TIMES, IT COULD NOT BE PULLED, AND GOT STRETCHED AT THE DISTAL PART. THE SUBJECT COIL WAS COLLECTED USING THE SNARE AND REPLACED WITH THE SAME DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425048 ↗
• MalfunctionJun 7, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE COIL (SUBJECT DEVICE) WAS INSERTING INTO THE NON-STRYKER MICROCATHETER, THE RESISTANCE WAS ENCOUNTERED AT THE SHAFT. THE MAIN COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER. 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 11951908 ↗
• MalfunctionJan 6, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS ATTEMPTED TO INSERT AND WAS MANIPULATED A FEW TIMES IN ORDER TO PLACE, BUT IT PREMATURELY DETACHED INSIDE THE OTHER COMPANY MICRO CATHETER. DETACHMENT SYSTEM WAS NOT USED TO DETACH THE SUBJECT COIL. PATIENT ANATOMY WAS NOTED TO BE VERY TORTUOUS. THE SUBJECT COIL WAS REMOVED ALONG WITH THE MICRO CATHETER. THEREAFTER, THE MICRO CATHETER WAS RE-INSERTED AND PROCEDURE CONTINUED USING REPLACEMENT COIL AND COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11122080 ↗