Nester G47329Recalls & reported problems
Cook Incorporated · Nester Embolization Microcoil · Class 2 · Implant
All models of Nester (38)
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 00827002473294), received between Mar 25, 2021 and Mar 3, 2022 — classified as 1 injury, 1 malfunction.
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.
Most reported problems
Device problems
- Difficult to Advance1
- Inadequacy of Device Shape and/or Size1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2022Material Separation; Inadequacy of Device Shape and/or Size; Material Separation; Inadequacy of Device Shape and/or Size
IT WAS REPORTED FOLLOWING DEPLOYMENT OF NESTER PLATINUM EMBOLIZATION MICROCOIL TO TREAT A TYPE 3 ENDOLEAK, THE COIL REMAINED STRETCHED INSTEAD OF COILING UP. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE COIL USING A SNARE, BUT IT "FELL APART." THE PATIENT HAD TO BE OPENED TO REMOVE THE DEVICE. AORTIC STENTS WERE ALSO REMOVED AND REPLACED, PRESUMABLY TO TREAT THE TYPE 3 ENDOLEAK. THE PHYSICIAN LATER CLARIFIED THAT THE COIL WAS DEPLOYED AND "NOT FAULTY," BUT SEPARATED DURING SNARING. HE ALSO STATED "EVERYTHING WENT FINE." NO OTHER ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13659199 ↗MalfunctionMar 25, 2021Difficult to Advance; 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 11567351 ↗
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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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