Nester G47333Recalls & reported problems
Cook Incorporated · Nester Embolization Microcoil · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002473331), received between Jun 30, 2022 and Jun 30, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- May 5, 2022Open, Classified
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Z-1241-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Entrapment of Device1
- 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.
MalfunctionJun 30, 2022Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance
IT WAS REPORTED A 91 YEAR OLD FEMALE PATIENT REQUIRED A NESTER PLATINUM EMBOLIZATION MICROCOIL FOR REPAIR OF AN ENDOLEAK FROM THE LUMBAR ARTERY. AFTER SUCCESSFULLY DEPLOYING TWO OTHER COILS, THE THIRD COIL BECAME LODGED AT THE DISTAL END OF THE CATHETER. THE USER TRIED TO DEPLOY IT BY FLUSHING WITH SALINE AND ALSO UTILIZING ANOTHER WIRE. BECAUSE THEY COULD NOT ADVANCE IT FURTHER, THE USER DECIDED TO PULL THE CATHETER WITH THE COIL 3/4 OF THE WAY OUT. WHEN THEY PULLED THE CATHETER RIGHT TOWARDS THE GROIN, THE COIL DISLODGED AND MIGRATED TO THE PERINEAL, WHERE IT NOW REMAINS OCCLUDING THAT VESSEL. THE PROCEDURE WAS CONCLUDED AT THIS POINT, BECAUSE IT WAS FOUND THE PATIENT HAD SUFFICIENT FLOW IN THE AFFECTED LEG VIA TWO OTHER PATENT VESSELS. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14878774 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- 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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