TARGET M0035474510Recalls & reported problems
Stryker Corporation · 360 Soft Detachable Coil · Class 2 · Implant
All models of TARGET (114)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540714787), received between Apr 20, 2021 and Sep 25, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE ANTERIOR COMMUNICATING ARTERY (ACOM ARTERY) SUBARACHNOID HEMORRHAGE (SAH) CASE, WHEN SUBJECT COIL WAS GETTING DEPLOYED INTO THE ANEURYSM, IT WAS FOUND THAT A PART OF THE SUBJECT COIL GOT BROKEN. WHEN THE SUBJECT COIL WAS RETRIEVED KINK LIKE SHAPE WAS FOUND BETWEEN THE FIRST LOOP AND THE SECOND LOOP OF THE SUBJECT COIL. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20306097 ↗MalfunctionApr 20, 2021Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING A.COM (ANTERIOR COMMUNICATING ARTERY) ANEURYSM ENDOVASCULAR COIL EMBOLIZATION PROCEDURE IN THE PATIENT WITH MULTI-VESSEL DISEASE, WHILE ADVANCEMENT OF THE SUBJECT COIL INTO THE MICROCATHETER IT SHOWED RESISTANCE FOR FURTHER CONTINUOUS INTRODUCTION OF THE COIL INSIDE ANEURYSM. SO THE OPERATOR TRIED TO WITHDRAW THE COIL WHICH GOT STUCK INTO THE MICROCATHETER AND DETACHED PREMATURELY WITHOUT ANY DETACHMENT ATTEMPT WITH DETACHMENT SYSTEM. THEREFORE OPERATOR WITHDREW THE MICROCATHETER FROM PATIENT VASCULATURE WITH THE PREMATURELY DETACHED COIL IN IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER SMOOTH DEPLOYMENT OF THE TWO COILS INTO THE TARGET ANEURYSM USING SAME MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11697876 ↗
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- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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