Nester G47327Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002473270), received between May 23, 2022 and Jun 30, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Unraveled Material” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION MICROCOIL UNRAVELED. DURING DEPLOYMENT, THE COIL BECAME STUCK IN THE PATIENT'S ARTERY. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, THE COIL UNRAVELED. MULTIPLE ATTEMPTS TO RETRIEVE THE STUCK COIL WERE UNSUCCESSFUL; THEREFORE, THE COIL REMAINS IN THE PATIENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Renal Impairment

  MAUDE report 14877192 ↗
• InjuryMay 23, 2022Unraveled Material; Difficult to Advance; Unraveled Material; Difficult to Advance

  IT WAS REPORTED A NESTER PLATINUM EMBOLIZATION MICROCOIL WAS DIFFICULT TO DEPLOY DURING A LEFT RENAL ARTERY EMBOLIZATION PROCEDURE. THE PHYSICIAN ACCESSED THE LEFT COMMON FEMORAL ARTERY AND PLACED A 6 FR SHORT SHEATH FOR ACCESS. AN 0.035 WIRE GUIDE WAS THEN ADVANCED INTO THE AORTA AND AN AORTOGRAM IDENTIFIED AND AIDED IN SELECTION OF THE LEFT RENAL ARTERY. A 6FR SUPPORT SHEATH WAS PLACED FOR SUPPORT. AN ANGIOGRAPHIC CATHETER AND WIRE GUIDE WERE ADVANCED THROUGH THE SUPPORT SHEATH AND ADVANCED INTO THE LEFT RENAL ARTERY. THE WIRE GUIDE WAS EXCHANGED. OVER THE WIRE AND THROUGH THE ANGIOGRAPHIC CATHETER, A 2.4 FR MICROCATHETER WAS PLACED IN THE RENAL ARTERY. THE WIRE WAS REMOVED AND COILING OF THE LEFT RENAL ARTERY COMMENCED WITH COMPETITOR COILS. AFTER SEVERAL COILS WERE PLACED, ADVANCEMENT OF AN UPSIZED 6MM X 14CM NESTER MICROCOIL WAS ATTEMPTED, HOWEVER THE PHYSICIAN DID NOT LIKE THE PLACEMENT AND THEREFORE REMOVED THE COIL USING THE MICROCATHETER. THE MICROCATHETER WAS THEN REINTRODUCED AND PLACEMENT OF A DOWNSIZED 4MM X 14CM NESTER COIL WAS ATTEMPTED USING A WIRE GUIDE. WHEN THE COIL WAS POSITIONED AT THE VERY DISTAL END OF THE MICROCATHETER, ABOUT 3-5 CM OF COIL REMAINED IN THE C

  Patient problems: Insufficient Information

  MAUDE report 14476708 ↗