Nester G26991Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002269910), received between Dec 4, 2017 and Dec 4, 2023 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2023Unraveled Material; Malposition of Device; Unraveled Material; Malposition of Device

  IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION COIL UNRAVELED. DURING THE PROCEDURE, THE COIL WAS "MAL-DEPLOYED" AND PROTRUDED INTO THE RENAL VEIN. WHEN THE COIL WAS RETRIEVED, IT UNRAVELED AND ELONGATED. A PROVIDED PHOTO SHOWS THE REPORTED FAILURE. 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 18260908 ↗
• InjuryJan 25, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Nerve Damage; No Code Available; Pain

  MAUDE report 11222818 ↗
• InjuryJan 2, 2020Migration; Migration

  IT WAS REPORTED BY A LAW FIRM "IN 2016, (PATIENT) SUFFERED FROM VARICOSE VEINS OF THE LOWER EXTREMITIES AND PELVIC CONGESTION SYNDROME." PATIENT ELECTED TO HAVE AN EMBOLIZATION PROCEDURE, DURING WHICH SEVERAL COOK NESTER AND TORNADO EMBOLIZATION COILS WERE IMPLANTED. REPORT STATES THE PATIENT "EXPERIENCED A LITANY OF HEALTH ISSUES UNTIL SHE HAD THE COILS REMOVED, INCLUDING: EXTREME PAIN; AUTOIMMUNE DIAGNOSES; DIFFICULTY WALKING; AND RENAL ISSUES. ON OR ABOUT (B)(6) 2018, PATIENT OPTED TO HAVE THE COILS REMOVED, AT WHICH TIME IT WAS FOUND THE COILS HAD PERFORATED AND MIGRATED. REPORT FURTHER STATES "AFTER THE COILS WERE REMOVED, PATIENT BEGAN TO FEEL RELIEF." MEDICAL RECORDS INDICATED THE FOLLOWING: ON (B)(6) 2016, PATIENT UNDERWENT BILATERAL COILING OF GONADAL VEINS DUE TO REFLUX AND DILATION. BILATERAL OVARIAN VEIN INSUFFICIENCY WITH MARKEDLY ENLARGED OVARIAN VEINS AND PELVIC VARICES WAS CONFIRMED. SUCCESSFUL BILATERAL OVARIAN VEIN COIL EMBOLIZATION DISTAL TO PROXIMAL WAS PERFORMED AND PERIODIC VENOGRAMS CONFIRMED STASIS AND CLOSURE OF OVARIAN VEIN BRANCHES. THERE WERE NO IMMEDIATE COMPLICATIONS AND UPON REMOVAL OF THE CATHETER AND SHEATH, HEMOSTASIS WAS ACHIEVED WITH MANUAL PRESS

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9538415 ↗
• MalfunctionDec 4, 2017Unraveled Material; Unraveled Material

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE COIL BECAME ELONGATED DURING AN UNSPECIFIED PROCEDURE. A PRELIMINARY INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT THE COIL HAD UNRAVELED. THE OPERATOR REPORTED THAT THE DEVICE WAS USED IN COMPLIANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE COILS WERE REPORTED TO BE "LOOKING OUT FROM THE ANEURYSM" AND WERE RETRACTED WITH RETRIEVAL FORCEPS CAUSING THE COILS TO BECOME ELONGATED. THE PROCEDURE WAS RESTARTED. THE CUSTOMER CONFIRMED NO PATIENT ADVERSE EVENTS RESULTED FROM THE ISSUE. THE INVESTIGATION OF THE COMPLAINT PRODUCT IS STILL ONGOING. THIS EVENT IS RELATED TO MDR #1820334-2017-04203

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7081831 ↗