MicroNester G52737Recalls & reported problems
Cook Incorporated · Micro Nester Embolization Coil · Class 2 · Implant
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 00827002527379), received between Sep 13, 2017 and Sep 13, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE INTERNATIONAL CUSTOMER REPORTED THAT, AFTER THE DEPLOYMENT OF THE NESTER PLATINUM EMBOLIZATION MICROCOIL, IT WAS NOTED BY THE OPERATOR OF THE DEVICE THAT THE COIL SIZE SEEMED DIFFERENT FROM WHAT WAS INDICATED ON THE PRODUCT LABEL. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL INTERVENTION WAS REQUIRED, AND NO ADVERSE EVENTS WERE REPORTED. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN. THE COILS ALSO REPORTEDLY MIGRATED. THE PRODUCT IS REPORTEDLY NOT AVAILABLE FOR RETURN; HOWEVER, IMAGES AND VIDEOS WERE PROVIDED FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6862094 ↗
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- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.