TARGET XL M0036121450Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540711540), received between Aug 16, 2016 and Apr 30, 2026 — classified as 6 injuries, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Premature Separation

  IT WAS REPORTED DURING THE EMBOLIZATION OF A UNRUPTURED ANEURYSM OF THE RIGHT ANTERIOR CEREBRAL ARTERY THE SUBJECT COIL DEPLOYED INSIDE THE CATHETER WHILE ADVANCING TO THE TREATMENT SITE. IT WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038729 ↗
• MalfunctionJul 5, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS FOUND PREMATURELY DEPLOYED INSIDE THE MICROCATHETER. NO FURTHER INFORMATION AVAILABLE AND THERE WAS NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 14916730 ↗
• InjuryMar 2, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT, STENT ASSISTED COIL EMBOLIZATION PROCEDURE WAS PERFORMED IN A PATIENT WITH ANEURYSM. DURING THE PROCEDURE THE PHYSICIAN ATTEMPTED TO DELIVER THE SUBJECT COIL THROUGH A NON-STRYKER MICROCATHETER. AFTER HAVING DEPLOYED FEW COILS INTO THE ANEURYSM THE PHYSICIAN DECIDED TO RETRIEVE THE SUBJECT COIL INTO THE MICROCATHETER TO ACCOMMODATE AND REARRANGE THE SUBJECT COIL INSIDE THE ANEURYSM IN A BETTER WAY. WHILE DOING THIS REARRANGEMENT, THE SUBJECT COIL GOT PREMATURELY DETACHED FROM THE DELIVERY WIRE. THE PHYSICIAN REMOVED THE PREMATURELY DETACHED SUBJECT COIL USING A RETRIEVER STENT. DUE TO DIFFERENT COMPLICATIONS, THE ORIGINAL PLAN OF THE PROCEDURE WAS MODIFIED AND THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF COILS ONLY. SURGICAL DELAY WAS NOTED AND THE DURATION OF THE SURGICAL DELAY IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED ON 1-MARCH-2022 STATED THAT INITIALLY REPORTED THROMBECTOMY PROCEDURE WHICH WAS PERFORMED DUE TO THE REPORTED ISSUE OF SUBJECT COIL, WAS NOT RELATED TO THE SUBJECT COIL AND IT SEEMS IT WAS CAUSED USING OTHER DEVICES DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654527 ↗
• MalfunctionMay 17, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE IN THE LEFT ANTERIOR COMMUNICATING ARTERY, THE PHYSICIAN SUCCESSFULLY CATHETERIZED THE ANEURYSM WITH A MICRO CATHETER. THE GUIDE WIRE WAS RETRACTED AND THE FIRST COIL WAS LOADED INTO THE MICRO CATHETER, BUT AFTER ADVANCING APPROXIMATELY ONE OR TWO THIRDS IN THE MICROCATHETER SHAFT, IT GOT STUCK IN THE MICRO CATHETER. WHEN THE PHYSICIAN TRIED TO PULL BACK THE FIRST COIL, IT DETACHED IN THE MICRO CATHETER AND BOTH DEVICES WERE REMOVED AND REPLACED WITH SIMILAR DEVICES. THE SAME EVENT HAPPENED WITH THE SECOND COIL AND MICRO CATHETER AND THE PHYSICIAN REMOVED AND REPLACED THEM WITH A THIRD SUBJECT COIL AND MICRO CATHETER WHICH ALSO HAD THE SAME EVENT HAPPEN. THIS CAUSED A 30 MINUTE SURGICAL DELAY. THE PHYSICIAN REMOVED THE THIRD SUBJECT COIL AND MICRO CATHETER AND REPLACED WITH SIMILAR DEVICES TO COMPLETE THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11830556 ↗
• InjuryJul 3, 2018Migration or Expulsion of Device; Premature Activation; Migration or Expulsion of Device; Premature Activation

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE COIL WAS PREMATURELY DETACHED INSIDE THE PATIENT WHEN IT WAS BEING REHEATED. THEREFORE, THE PHYSICIAN USED A RETRIEVER DEVICE TO REMOVE THE DETACHED COIL FROM THE PATIENT. THE PROCEDURE WAS ABORTED AND THEN RESUMED THE OTHER DAY. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7660384 ↗
• InjuryMar 21, 2017Premature Activation; Premature Activation

  DURING THE COIL EMBOLIZATION, IT WAS REPORTED THAT THE COIL WAS DETACHED. THE COIL GOT STUCK ON A STENT (NON-STRYKER) AND WHEN TRYING TO PULL BACK THE COIL IT BECAME DETACHED. A SNARE WAS USED TO REMOVE THE DETACHED COIL FROM THE PATIENT. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6423146 ↗
• InjuryNov 16, 2016Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  THE PATIENT PRESENTED WITH A RUPTURED LARGE SUPRACLINOID RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH SUBARACHNOID HEMORRHAGE AND MILD HYDROCEPHALUS. DURING EMBOLIZATION OF THE ANEURYSM, THE FIST COIL WAS PLACED INSIDE THE ANEURYSM BUT STRETCHED OUT OF THE ANEURYSM AND DOWN THE VASCULATURE AND BROKE OFF THE DELIVERY WIRE. FOLLOWING UNSUCCESSFUL ATTEMPTS TO RETRIEVE THE COIL, A STENT WAS PLACED TO SECURE THE BROKEN STRETCHED COIL AGAINST THE RIGHT ICA WALL. THE SAME ISSUE WAS OCCURRED WITH THE SECOND COIL (SUBJECT COIL). THE THIRD COIL WAS UNEVENTFULLY PLACED; HOWEVER, AFTER THE LAST COIL DEPLOYMENT, THROMBUS FORMATION WAS NOTED AT THE TREATED VESSEL. INTRA-ARTERIAL INTEGRILIN WAS GIVEN TO THE PATIENT TO TREAT THE VESSEL THROMBOSIS. THE PATIENT HAD LONG TERM DEFICIT WITH SPEECH, COGNITIVE AND LINGUISTIC DEFICITS REQUIRING 24 HOUR SUPERVISION FOR SAFETY. IT IS UNKNOWN IF THE PATIENTS CONDITION POST-PROCEDURE RELATED TO THE REPORTED DEVICES MALFUNCTION AND SUBSEQUENT THROMBOSIS OR TO THE PATIENTS PRESENTING CONDITION BEFORE PROCEDURE.

  Patient problems: Thrombosis

  MAUDE report 6105930 ↗
• InjurySep 14, 2016Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A RUPTURED DISTAL RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM, DURING REPOSITIONING, THE FIRST SUBJECT COIL AND THEN THE SECOND COIL PROXIMAL SECTION STRETCHED AND BOTH MAIN COILS BROKE. THERE WERE ATTEMPTS TO RETRIEVE THE FIRST COIL BY 2 DIFFERENT SNARE DEVICES. A 3RD COIL WAS PLACED UNEVENTFULLY. THROMBUS FORMED IN THE TREATED VESSEL AFTER PLACEMENT OF THE 3RD COIL. PLATELET AGGREGATION INHIBITOR WAS ADMINISTERED. A STENT WAS PLACED IN THE CAROTID BULB TO TACKLE DOWN TWO BROKEN COILS. COMPLETE COILING OF THE ANEURYSM WAS ACHIEVED. PATIENT CLINICAL CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; Neurological Deficit/Dysfunction; No Known Impact Or Consequence To Patient; Thrombosis

  MAUDE report 5949428 ↗
• InjuryAug 16, 2016Break; Break

  IT WAS REPORTED THAT DURING ANEURYSM COILING EMBOLIZATION, ONLY A PORTION OF THE COIL COULD EXIT FROM THE MICROCATHETER AND INTO THE ANEURYSM. THE PHYSICIAN WAS UNABLE TO ADVANCE OR RETRACT THE COIL AND DURING AN ATTEMPT TO REMOVE IT, THE COIL BROKE. THE PROXIMAL SECTION OF THE COIL WAS INSIDE THE MICROCATHETER AND THE DISTAL SEGMENT WAS INSIDE THE ANEURYSM. THE PHYSICIAN USED A GOOSENECK SNARE DEVICE "TO CATCH THE COIL INSIDE THE MICROCATHETER" AND CUT THE MICROCATHETER TO REMOVE THE COIL AND THEN REMOVE THE MICROCATHETER FROM THE PATIENT'S BODY. THE PHYSICIAN CONTINUE THE PROCEDURE WITH ANOTHER COIL AND MICROCATHETER. THERE WAS NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5879349 ↗