Nester G23532Recalls & reported problems
Cook Incorporated · Nester Embolization Coil · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002235328), received between Oct 14, 2021 and Oct 14, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Abdominal Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CONTACT WAS MADE WITH THE SURGEON AND ADDITIONAL INFORMATION RELATED TO THE EVENT WAS REPORTED. THE SURGEON STATED: "I DON¿T THIS THE PATIENTS DISCOMFORT HAD ANYTHING TO DO WITH THE DEVICE. IT WAS SIMPLY A BIG VEIN WITH A LOT OF PELVIC VARICES. ITS APPROPRIATE PHLEBITIS CONSISTENT WITH THROMBOSIS OF THE VEIN. FURTHER THIS IS NOT A COMPLAINT IT IS AN OBSERVATION. SOMETHING THE CLINICIAN WILL HAVE TO BALANCE UP WHEN THEY OFFER RX FOR THIS ISSUE. DISCOMFORT OR TREATING THE VEIN VS THE BENEFIT OR OCCLUDING IT."
Patient problems: Abdominal Pain
MAUDE report 12632428 ↗
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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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