TARGET M0035452020Recalls & reported problems
Stryker Corporation · Helical Nano 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 07613252600350), received between Jul 15, 2019 and Mar 14, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2022Fracture; Fracture
THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT MAIN COIL WAS FRACTURED/BROKEN DURING USE. THEREFORE, THIS EVENT MEETS THE REQUIREMENTS OF A REPORTABLE EVENT WITH AN AWARENESS DATE OF 17-FEB-2022 (VN)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13759040 ↗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 8788887 ↗
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- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
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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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