Nester G26993Recalls & reported problems
Cook Incorporated · Nester Embolization Coil · Class 2 · Implant
All models of Nester (38)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002269934), received between Oct 21, 2019 and Oct 19, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (2 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
Device problems
- Difficult to Advance2
- Entrapment of Device2
- Unraveled Material2
- Failure to Advance1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2022Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15633150 ↗MalfunctionAug 5, 2021Entrapment of Device; Unraveled Material; Failure to Advance; Entrapment of Device; Unraveled Material; Failure to Advance
IT WAS REPORTED A MALE PATIENT REQUIRED PLACEMENT OF A NESTER PLATINUM EMBOLIZATION COIL FOR A RIGHT HYPOGASTRIC ARTERY EMBOLIZATION. DURING THE PROCEDURE, THE COIL "DID NOT SHAPE" NOR EXIT THE CATHETER. AFTER MANEUVERING WITH THE GUIDEWIRE AND SALINE UNDER PRESSURE, THE COIL PARTIALLY EXITED THE CATHETER. A PHOTO PROVIDED BY THE FACILITY SHOWS AN ELONGATED COIL WITH BIOLOGICAL MATTER PRESENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12284497 ↗InjuryOct 21, 2019Material Separation; Unraveled Material; Difficult to Advance; Material Separation; Unraveled Material; Difficult to Advance
Other Device, Vascular, for Promoting Embolization devices
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- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 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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