Target M0036155100Recalls & reported problems
Stryker Corporation · 3D 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540711687), received between Dec 10, 2024 and May 23, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Expulsion” (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
- Expulsion1
- Fracture1
- Migration1
Patient problems
- Embolism/Embolus1
- Movement Disorder1
- No Clinical Signs, Symptoms or Conditions1
- Speech Disorder1
- Vasoconstriction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2025Migration; Migration
IT WAS REPORTED THAT AFTER THE SUCCESSFULLY DEPLOYMENT OF THE SUBJECT DEVICE, IT WAS OBSERVED THAT THE SUBJECT DEVICE WAS MISPLACED AND STRETCHED. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22080085 ↗InjuryDec 10, 2024Fracture; Expulsion; Fracture; Expulsion
IT WAS REPORTED THAT DURING PROCEDURE AT RIGHT INTERNAL CAROTID ARTERY-OPHTHALMIC, THE SUBJECT COIL WAS FRACTURED, AS THE SUBJECT COIL WAS STRETCHED AND DISLOCATION. THEREFORE, THE STENT WAS USED AS JAILING TECHNIQUE WHICH CAUSED THE PROCEDURE PROLONGED APPROXIMATELY 60 MINUTES AND INPATIENT HOSPITALIZATION. AFTER THE STUDY PROCEDURE, BUT WITHIN 48 HOURS AFTER PROCEDURE, THE PATIENT EXPERIENCED WITH WORD FINDING DISORDER AND FINE MOTOR DISORDER LEFT HAND. THE OUTCOME WAS RESOLVED, WITHOUT SEQUELAE. RAYMOND SCORE POST PROCEDURE WAS 2 - RESIDUAL NECK/DOG EAR DEFINED AS THE PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL. UPDATE: ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 STATED THAT PATIENT ALSO EXPERIENCED MULTIPLE MICRO EMBOLIC INFARCTIONS ON THE RIGHT, FEW ON THE LEFT SIDE RESULTING IN WORD FINDING DISORDER AND FINE MOTOR DISORDER LEFT HAND. THE PATIENT NEUROLOGICAL ASSESSMENT ON (B)(6) 2024 SHOWED MRS (MODIFIED RANKIN SCORE) SCORE OF 2 AND NIHSS (NATIONAL INSTITUTE OF HEALTH STROKE SCALE) SCORE OF 4.
Patient problems: Embolism/Embolus; Movement Disorder; Speech Disorder; Vasoconstriction
MAUDE report 20888962 ↗
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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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