TARGET M0035422540Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04546540675866), received between Jun 9, 2016 and Aug 25, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Adverse Event Without Identified Device or Use Problem; Migration

  It was reported that during an aneurysm embolization procedure, a first subject coil was successfully placed in the aneurysm. A second coil was subsequently introduced but was determined not to be a suitable fit and was retracted into the microcatheter. During retraction of the second coil, the first subject coil was unintentionally retracted from its implanted position. The physician reported no resistance during the event. Additional coil placement was subsequently attempted. The event resulted in an approximate 10-minute procedural delay. Additional coil placement was subsequently attempted, after which the aneurysm ruptured. The patient was transferred to neurosurgery for clipping. The physician reported that the patient was not expected to survive. No additional information is available.Update:Additional information received on 16-Sept-2026 confirmed that an aneurysm rupture was reported in association with the subject coil (Third coil). The aneurysm rupture occurred during the attempt to place the subject coil. The patient was transferred to neurosurgery for clipping. The physician reported that the patient was not expected to survive. The event resulted in an approximate 10-

  Patient problems: No Clinical Signs, Symptoms or Conditions; Ruptured Aneurysm

  MAUDE report 50434982 ↗
• InjuryAug 25, 2026Inadequacy of Device Shape and/or Size; Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem

  It was reported that during an aneurysm embolization procedure, a first coil was placed in the aneurysm. A second coil was determined not to be a good fit and was retracted into the microcatheter. During retraction, the first coil was also retracted. The physician reported that no resistance was encountered. A new subject coil was then attempted, after which the aneurysm ruptured. The consultant stated that the aneurysm rupture was caused by the coil. The event resulted in a 10-minute surgical delay. The patient was subsequently transferred to the neurosurgery department for clipping. The consultant stated that the patient would most likely not survive. No additional information available

  Patient problems: No Clinical Signs, Symptoms or Conditions; Ruptured Aneurysm

  MAUDE report 50434978 ↗
• MalfunctionApr 3, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ACUTE COILING PROCEDURE, AN ATTEMPT WAS MADE TO DELIVER THE SUBJECT COIL THROUGH THE MICROCATHETER, BUT IT WOULD NOT ADVANCE. WHEN RETRIEVAL WAS ATTEMPTED, THE COIL REMAINED STUCK AND EVENTUALLY SNAPPED WITHIN THE MICROCATHETER. THE PROCEDURE WAS DELAYED BY 15 MINUTES, WITH NO ADVERSE IMPACT ON THE PATIENT. 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 21762348 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A STENT-COILING OF AN UNRUPTURED ACOMM (ANTERIOR COMMUNICATING ARTERY) ANEURYSM, THERE WAS AN INTRAPROCEDURAL RUPTURE OF THE ANEURYSM DOME. THE PHYSICIAN HAD SUCCESSFULLY PLACED STRYKER STENT FROM THE A2 TO A1, AND HAD SUCCESSFULLY DETACHED STRYKER COIL INSIDE THE ANEURYSM DOME. BUT, AFTER PLACEMENT AND DETACHMENT OF THE SUBJECT COIL (SECOND COIL), THE PHYSICIAN DID AN ANGIOGRAPHIC RUN, AND NOTICED EXTRAVASATION COMING FROM THE ANEURYSM DOME. HE TRIED TO QUICKLY PLACE A THIRD COIL, BUT THE MICROCATHETER HAD BACKED OUT OF THE ANEURYSM DOME. SO, HE USED A BALLOON AS A MEDICAL INTERVENTION, AND INFLATED IT NEAR THE ICA (INTERNAL CAROTID ARTERY) TERMINUS TO STOP THE FLOW OF BLOOD TO THE ACOMM FOR ABOUT A MINUTE. ONCE THE BALLOON WAS DEFLATED, HE DID ANOTHER ANGIOGRAPHIC RUN, AND THE EXTRAVASATION HAD STOPPED. AFTER THE CASE, THE PHYSICIAN PERFORMED A CT SCAN, AND COMMENTED THAT BOTH THE CT SCAN RESULTS AND THE PATIENT WERE FINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Extravasation; Intracranial Hemorrhage; Ruptured Aneurysm

  MAUDE report 15882821 ↗
• MalfunctionAug 5, 2020Activation Problem

  DURING CERVICAL AND CEREBRAL ANGIOGRAM AND COILING, 3 STRYKER TARGET COILS FAILED TO DEPLOY. THE PROCEDURE WAS CARRIED OUT WITH NO COMPLICATIONS. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, TARGET (PER SITE REPORTER). ASKED THAT IT BE RETURNED FOR ANALYSIS, AND SENT SHIPPING MATERIAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10367023 ↗
• MalfunctionMay 7, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHILE DEPLOYING THE SUBJECT COIL, THE COIL DIDN'T GO COMPLETELY INTO THE LUMEN OF ANEURYSM AND THE TIP OF MICROCATHETER WENT OUT OF THE ANEURYSM. THE PHYSICIAN WITHDREW THE SUBJECT COIL SLOWLY AND FOUND THE TIP OF COIL WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REPLACED THE COIL AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10037030 ↗
• InjuryNov 4, 2019Adverse 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 STUCK IN THE DISTAL PART OF THE MICROCATHETER. THE OPERATOR HAD TO CUT THE HUB OF THE MICROCATHETER TO REMOVE THE COIL WITH A SNARE DEVICE. THE COIL WAS NOTED TO BE STRETCHED ONCE REMOVED FROM THE PATENT¿S ANATOMY. NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9274575 ↗
• MalfunctionJul 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT SUCCESSFULLY UNDERWENT COIL EMBOLIZATION FOR AN ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH 4 COILS (SUBJECT DEVICE) AND A MICROCATHETER. NEXT DAY MAGNETIC RESONANCE IMAGING (MRI) SHOWED AN ARTIFACT. THE CT IMAGE SHOWED NO SIGN. ACCORDING TO THE PHYSICIAN, THE ARTIFACT MAY BE A MARKER FOR THE PRODUCT USED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8788857 ↗
• MalfunctionApr 29, 2019Break; Break

  BASED ON REVIEW OF THE INVESTIGATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE MAIN COIL (SUBJECT DEVICE) WAS BROKEN WITHIN THE MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562178 ↗
• MalfunctionOct 19, 2018Failure to Advance

  THE COIL WOULD NOT PASS THROUGH THE INTRODUCER SHEATH. THE COIL DID NOT TOUCH THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7983443 ↗
• MalfunctionJun 27, 2018Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  DURING A STENT ASSISTED COILING PROCEDURE, THE COIL (SUBJECT DEVICE) BECAME ENTANGLED WITH EXISTING COIL MASS AND WAS NOT ABLE TO BE REMOVED. IT WAS REPORTED THE COIL STRETCHED, WAS PROTRUDING FROM THE ANEURYSM AND BROKE. A SECOND STENT WAS USED TO PUSH THE COIL AT THE VESSEL WALL. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643832 ↗
• MalfunctionJun 9, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE RESISTANCE WAS ENCOUNTERED WHEN THE SUBJECT COIL WAS ADVANCED THROUGH THE MICROCATHETER'S SHAFT. THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL AND UPON REMOVAL THE MAIN COIL HAD PREMATURELY DETACHED IN THE HUB OF THE MICROCATHETER. THE DETACHED COIL WAS REMOVED FROM THE HUB AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5710309 ↗