Nester G47345Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002473454), received between Aug 25, 2022 and Nov 2, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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. 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.

• 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 14X4 OR 14X10 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 15715755 ↗
• MalfunctionAug 25, 2022Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION MICROCOIL BECAME LODGED IN THE CATHETER DURING A TYPE 2 ENDOLEAK REPAIR. THE ANATOMICAL TARGET WAS AN AORTIC ANEURYSM AND THE VESSEL WAS APPROXIMATELY 7 CM. THE USER ATTEMPTED TO DEPLOY THE COIL USING A COMPETITOR'S CATHETER AND THE WIRE GUIDE AND FLUSH TECHNIQUE BUT THE COIL LODGED IN THE CATHETER. THE CATHETER AND AND COIL WERE THEN REMOVED WITH ABOUT HALF A CENTIMETER OF COIL EXITING THE DISTAL TIP OF THE CATHETER. AN ADDITIONAL WIRE ALONGSIDE THE COIL WAS OBSERVED, WHICH PREVENTED THE COIL FROM ADVANCING. A NEW, LIKE COIL AND CATHETER WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS NOTED THAT A COIL FROM THE SAME LOT HAD BEEN PLACED SUCCESSFULLY PRIOR TO THE FAILURE AND THAT THE CATHETER WAS FLUSHED BEFORE EACH COIL DEPLOYMENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292270 ↗