Nester G47352Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002473522), received between May 3, 2021 and Jan 12, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2024
DEVICE WAS DAMAGED AND NOT PLACED IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502132 ↗MalfunctionAug 30, 2023Difficult to Advance; Difficult to Advance
IN ADDITIONAL INFORMATION RECEIVED ON 31AUG2023, IT WAS CONFIRMED THAT THE CATHETER WAS FLUSHED WITH SALINE PRIOR TO COIL INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17652940 ↗MalfunctionMay 3, 2021Failure to Advance; Failure 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 11760238 ↗
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- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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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