Nester G47346Recalls & reported problems
Cook Incorporated · Nester Embolization Coil · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002473461), received between Nov 2, 2022 and Nov 2, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
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.
InjuryNov 2, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION MICROCOIL DID NOT FORM PROPERLY IN THE 8MM VESSEL OF AN UNKNOWN MALE PATIENT DURING EMBOLIZATION PROCEDURE FOR A SPLENIC BLEED. AS THE PHYSICIAN PLACED THE COIL INTO THE PATIENT, IT DID NOT FORM INTO A COIL. ANOTHER COIL WAS USED BUT EXHIBITED THE SAME FAILURE. THE DEVICE WAS THEN REMOVED AND REPLACED WITH A THIRD LIKE DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CUSTOMER NOTED THAT THE COIL SIZES WERE 14X12 AND EITHER 14X4 OR 14X10 FOR THE OTHER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. THE DEVICE WAS REPORTED TO BE DISCARDED BY THE FACILITY. THIS REPORT CAPTURES ONE INSTANCE OF THE 14X12 COIL NOT FORMING CORRECTLY. THE SECOND OCCURRENCE IS REFERENCED IN A REPORT WITH PATIENT IDENTIFIER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15714861 ↗
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- Prestige Coil System PRES0520HPKPLBalt 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- 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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