Nester G47325Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002473256), received between Apr 14, 2022 and Apr 14, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure 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
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2022Failure to Advance; Failure to Advance
IT WAS REPORTED A PATIENT REQUIRED PLACEMENT OF A NESTER PLATINUM EMBOLIZATION MICROCOIL FOR EMBOLIZATION OF GASTRIC VARICES USING AN ECHOENDOSCOPE. THE COIL WAS PUSHED THROUGH THE INTRODUCER ON THE PROXIMAL END OF AN ENDOSCOPIC ULTRASOUND FINE NEEDLE UNTIL IT WAS FULLY INSIDE THE NEEDLE, AND THEN THE STYLET NEEDLE WAS USED TO PUSH THE COIL. HOWEVER, THE OPERATOR COULD NOT ADVANCE THE COIL INTO THE PATIENT. THE PHYSICIAN REMOVED THE DEVICE AND ATTEMPTED AGAIN WITH ANOTHER COIL OF THE SAME LOT. THE SAME DIFFICULTY WAS EXPERIENCED. THE PROCEDURE WAS UNABLE TO BE COMPLETED. THE PHYSICIAN DECIDED TO CONTINUE WATCHING THE PATIENT AND MAY ATTEMPT TO COMPLETE THE PROCEDURE AT A LATER DATE. AT THIS TIME, THERE IS NO CONFIRMATION OF A PLANNED ADDITIONAL PROCEDURE. IMAGES PROVIDED FROM THE CUSTOMER SHOW BOTH COILS PARTIALLY EXITED THE TIP OF THE NEEDLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14110984 ↗
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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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