TARGET M0035476200Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04546540676542), received between Jun 26, 2018 and Apr 6, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN TRIED TO ADVANCE THE SUBJECT MICROCATHETER BUT AFTER CERTAIN DISTANCE, FURTHER ADVANCEMENT WAS NOT POSSIBLE. UPON WITHDRAWAL AND ADJUSTMENT, THE PHYSICIAN FOUND THAT THE SUBJECT COIL REMAINED UNMOVED. THE SUBJECT COIL WAS THEN WITHDRAWN FROM THE MICROCATHETER, AND WHILE FLUSHING IT WITH LIQUID ON THE OPERATING TABLE, THE PHYSICIAN PUSHED THE SUBJECT COIL OUT OF THE MICROCATHETER AND CONFIRMED PREMATURE DETACHMENT. THE SUBJECT DEVICE WAS REPLACED, AND 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 24793775 ↗
• MalfunctionJan 13, 2026Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE. 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 24064079 ↗
• MalfunctionNov 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE; AFTER ADVANCING THE SUBJECT COIL INTRODUCING SHEATH INTO THE MICROCATHETER, THE PHYSICIAN PUSHED THE SUBJECT COIL FORWARD. WHEN APPROXIMATELY 20 CM OF THE DELIVERY WIRE REMAINED OUTSIDE THE INTRODUCING SHEATH, THE SUBJECT COIL COULD NO LONGER BE ADVANCED INTO THE INTRODUCING SHEATH. THE PHYSICIAN THEN WITHDREW THE SUBJECT COIL OUT OF THE BODY AND FOUND THAT THE JUNCTION BETWEEN THE SOFT AND STIFF SECTIONS IN THE MIDDLE OF THE DELIVERY ROD HAD BROKEN. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610129 ↗
• MalfunctionOct 2, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE ICA (INTERNAL CAROTID ARTERY) PROCEDURE, THE COIL (SUBJECT DEVICE) DETACHED PREMATURELY IN THE MICROCATHETER SHAFT. 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 20352865 ↗
• MalfunctionFeb 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING LEFT ICA (INTERNAL CAROTID ARTERY) OA ANEURYSM EMBOLIZATION CASE WHEN ADVANCING THE COIL (SUBJECT DEVICE) INTO ANEURYSM, SLIGHT RESISTANCE WAS ENCOUNTERED INSIDE THE CATHETER. WHEN THE OPERATOR ADJUSTING ITS POSITION IN ANEURYSM AFTER FILLING, THE DISTAL END OF THE COIL (SUBJECT DEVICE) DELIVERY WIRE FRACTURED. THE OPERATOR WITHDREW THE MICROCATHETER AND THE DELIVERY WIRE OUT TOGETHER TOGETHER WITH THE FRACTURED TIP. 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 16414986 ↗
• MalfunctionOct 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE INTERCRANIAL COILING OF AN ICA (INTERNAL CAROTID ARTERY) ANEURYSM PROCEDURE, SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO PLACE THE COIL (SUBJECT DEVICE) INTO THE ANEURYSM. CONTINUED ADVANCEMENT OF THE COIL LED TO DISLOCATION OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO REMOVE THE SUBJECT DEVICE AND THE COIL BROKE. A SECTION OF THE COIL REMAINED IN THE ANEURYSM AND THE OTHER SECTION REMAINED OUTSIDE OF THE ANEURYSM AND WAS TREATED WITH TWO STENTS. 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 15672666 ↗
• InjuryJan 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL TRIAL PROCEDURE TO TREAT A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE PATIENT HAD HEMIANOPIA AND DELIRIUM. ON IMAGING, OCCIPITAL MICRO EMBOLIC INFARCTS WERE SEEN WHICH RESULTED IN PROLONGED HOSPITALIZATION FOR THE PATIENT. THE EVENT WAS TREATED WITH PHYSIOTHERAPY AND ORAL OLANZAPIN 5 MG FOR DELIRIUM FOR 5 DAYS AND RECOVERED. IN THE PHYSICIAN'S OPINION, THE EVENT WAS POSSIBLY RELATED TO THE SUBJECT DEVICE AND OTHER STRYKER DEVICES USED IN THE PROCEDURE.

  Patient problems: Cognitive Changes; Visual Impairment

  MAUDE report 13262425 ↗
• MalfunctionOct 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, WHEN THE SUBJECT COIL WAS INSERTED INTO THE MICROCATHETER IT WAS CONFIRMED THAT THE DELIVERY WIRE OF THE SUBJECT COIL WAS FRACTURED AND WAS DISCONTINUED TO USE. 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 12723163 ↗
• MalfunctionOct 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL WAS BROKEN/FRACTURED PRIOR TO DEPLOYING. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12641596 ↗
• MalfunctionDec 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE DELIVERY WIRE OF THE COIL (SUBJECT DEVICE) FRACTURED DURING THE PROCEDURE. THE SUBJECT COIL FAILED TO BE DETACHED DUE TO THE FRACTURE ON THE DELIVERY WIRE. 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 10948184 ↗
• InjuryNov 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS DONE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT BIFURCATION FOR AN ANEURYSM SIZED 6.2MM BY 6.8MM. PHYSICIAN USED THE SUBJECT COIL AND WHILE ADJUSTING ENCOUNTERED RESISTANCE. THE SUBJECT COIL WAS RETRACTED AND ITS DISTAL PORTION WAS BROKEN. THE SUBJECT COIL FRAGMENT WAS COMPLETELY REMOVED FROM THE PATIENT¿S ANATOMY WITHOUT A SNARE. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED PRESENCE OF AN UNSTABLE THROMBUS IN THE ANEURYSM, SO PHYSICIAN USED UROKINASE FOR THROMBOLYSIS. AFTER 10 MIN, THE THROMBUS HAD COMPLETELY RESOLVED. CONSIDERING THE SAFETY OF THE PROCEDURE, THE PHYSICIAN DECIDED TO DO ANOTHER SURGERY LATER. IT WAS REPORTED THAT THE PATIENT HAD UNKNOWN CLINICAL CONSEQUENCES DUE TO THE EVENT. ONE MONTH LATER, AN UNKNOWN RETREATMENT PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10868959 ↗
• MalfunctionNov 16, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE OF THE ANEURYSM EMBOLIZATION CASE, THE OPERATOR USED COIL TO FRAME AND MICROCATHETER TO SUPPORT. AFTER INTRODUCING THE COIL FROM INTRODUCING SHEATH TO GO INTO THE MICROCATHETER, THE OPERATOR CHECKED UNDER X-RAY FOR THE COIL STRETCHED AND DECIDED TO WITHDRAW THE COIL. WHILE RETRACTING THE COIL (SUBJECT DEVICE) FROM THE HUB OF MICROCATHETER, IT GOT PRE DETACHED. 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 10848350 ↗
• MalfunctionMay 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS ATTEMPTED TO PLACE AND RE-POSITIONED SEVERAL TIMES AND THE SUBJECT COIL BECAME STRETCHED UNDER FLUOROSCOPY. THE SUBJECT COIL DELIVERY WIRE WAS FOUND TO BE FRACTURED APPROXIMATELY 3CM FROM THE COIL JUNCTION DURING RETRACTION. PHYSICIAN USED A SNARE DEVICE TO RETRIEVE THE FRACTURED PORTION FROM THE ANEURYSM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10022572 ↗
• MalfunctionNov 21, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE COIL PREMATURELY DEPLOYED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9359788 ↗
• MalfunctionSep 19, 2019Premature Separation; Premature Separation

  BASED ON THE INVESTIGATION REVIEW IT WAS REPORTED THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED INSIDE THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9090486 ↗
• MalfunctionJun 26, 2018Break; Break

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL WAS BROKEN/FRACTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7636868 ↗