TARGET M0035452030Recalls & reported problems
Stryker Corporation · Helical Nano Detachable Coil · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252600367), received between Jan 9, 2018 and Sep 13, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Premature Activation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Premature Activation1
- Premature Separation1
- Unintended Movement1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2019Premature Separation; Premature Separation
DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE MAIN COIL WAS PREMATURELY DETACHED INSIDE THE PATIENT. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9042026 ↗MalfunctionOct 2, 2018Unintended Movement; Unintended Movement
A (B)(6) FEMALE (HYPERTENSION, PREVIOUS SMOKER) UNDERWENT STENT ASSISTED COIL EMBOLIZATION OF ANEURYSM IN RIGHT MIDDLE CEREBRAL ARTERY (MCA) (B)(6) 2017. WHEN THE PATIENT WAS SEEN FOR FOLLOW-UP APPROXIMATELY ONE YEAR LATER (B)(6) 2018, IT WAS REPORTED THE COIL MIGRATED THROUGH THE STENT STRUTS AND WAS PROTRUDING SLIGHTLY INTO THE ARTERY, AS OBSERVED ON DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT; THE EVENT WAS NOTED TO RESOLVE WITHOUT SEQUELAE THE SAME DAY ((B)(6) 2018). ADDITIONAL INFORMATION FROM THE PHYSICIAN INDICATED THE STENT WAS USED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7928878 ↗MalfunctionJan 9, 2018Premature Activation; Premature Activation
BASED ON THE ANALYSIS OF THE DEVICE, IT WAS FOUND THAT THE MAIN COIL WAS PHYSICALLY DETACHED FROM THE DELIVERY WIRE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7177422 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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