Nester G26992Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002269927), received between Apr 6, 2016 and Apr 18, 2023 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2023Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THERE WAS INCIDENT INVOLVING A NESTER PLATINUM EMBOLIZATION COIL. AFTER THE NESTER COIL WAS DEPLOYED IN AN UNKNOWN PATIENT, THE NESTER COIL WOULD NOT COIL, BUT REMAINED MORE STRAIGHT. AS A RESULT, THE PHYSICIAN DEPLOYED A STENT TO KEEP THE COIL IN PLACE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765553 ↗
• MalfunctionJan 16, 2023Entrapment of Device; Material Separation; Stretched; Difficult to Advance; Entrapment of Device; Material Separation; Stretched; Difficult to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16174278 ↗
• MalfunctionMay 5, 2022Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  IT WAS REPORTED A NESTER PLATINUM EMBOLIZATION COIL FAILED TO DEPLOY IN AN (B)(6) MALE PATIENT DURING A FALSE LUMEN EMBOLIZATION PROCEDURE. THE PHYSICIAN ATTEMPTED TO PUSH THE COIL THROUGH THE CATHETER, BUT IT BECAME STUCK IN THE TIP OF THE CATHETER. THE CATHETER WAS REMOVED AND ANOTHER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. PHOTOS PROVIDED BY THE CUSTOMER SHOWED THE COIL LODGED IN THE DISTAL TIP OF THE CATHETER. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288215 ↗
• InjuryMay 27, 2021Inadequacy of Device Shape and/or Size; Stretched; Inadequacy of Device Shape and/or Size; Stretched

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893384 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT NUMEROUS ISSUES WERE EXPERIENCED BY A PATIENT THAT HAD NESTER PLATINUM EMBOLIZATION COILS IMPLANTED. IN AN INITIAL PROCEDURE ON (B)(6) 2014, AN UNKNOWN QUANTITY OF NESTER EMBOLIZATION COILS WERE IN PLANTED IN THE PATIENT. ON (B)(6) 2014, THE PATIENT HAD A VARICOCELE EMBOLIZATION PROCEDURE OF THE RIGHT INTERIOR ILIAC VEIN. DURING THE PROCEDURE, SEVERAL NESTER EMBOLIZATION COILS WERE IMPLANTED. SHORTLY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A LITANY OF HEALTH ISSUES INCLUDING SEVERE PAIN, ALTERED IMMUNE SYSTEM AND SEVERE AUTOIMMUNE ISSUES. THE PATIENT'S DOCTOR SUGGESTED THAT THE COILS MAY BE THE CAUSE OF THE PAIN AND SHOULD BE REMOVED. AT THE TIME OF THIS REPORT, THE COILS HAVE NOT BEEN REMOVED, HOWEVER THE PATIENT IS ON A WAITLIST FOR THE SURGERY. THIS COMPLAINT CAPTURES TWO OF THE SEVEN COOK COILS PLACED IN THE PROCEDURE ON (B)(6) 2014, NESTER PLATINUM EMBOLIZATION COIL (RPN: MWCE-35-14-12-NESTER, LOT NUMBER 4711539)- QTY 2. COILS IMPLANTED ON (B)(6) 2014, AS WELL AS THE OTHER FIVE COILS FROM THE PROCEDURE ON (B)(6) 2014 ARE CAPTURED IN REPORTS WITH PATIENT IDENTIFIER (B)(6). ADDITIONAL INFORMATION REGARDING THE PROCEDURE WAS PROVIDED ON (B)(6) 2021. CENE

  Patient problems: Autoimmune Disorder; Pain

  MAUDE report 11240374 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

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

  Patient problems: Autoimmune Disorder; Pain

  MAUDE report 11240368 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

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

  Patient problems: Autoimmune Disorder; Pain

  MAUDE report 11240286 ↗
• 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 11223118 ↗
• InjuryJan 25, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY A LAW FIRM, (PATIENT) SUFFERED FROM SWELLING OF A VEIN RESULTING IN PAIN AND WAS DIAGNOSED WITH PELVIC CONGESTION SYNDROME AND PELVIC VENOUS VERICOSITIES AS WELL AS GROIN AND BACK PAIN. ON OR ABOUT (B)(6) 2018, PATIENT ELECTED TO HAVE A VARICOCELE EMBOLIZATION PROCEDURE DURING WHICH COOK NESTER EMBOLIZATION COILS WERE IMPLANTED. SHORTLY AFTER THE PROCEDURE THE PATIENT ALLEGEDLY BEGAN TO EXPERIENCE A LITANY OF HEALTH ISSUES INCLUDING URETER DAMAGE RESULTING IN KIDNEY AND OVARY AUTO-TRANSPLANT, INFECTIONS, DEPRESSION; NERVE DAMAGE, ALLERGIC REACTION, LEFT FLANK PAIN, AND NUTCRACKER PHENOMENON. THE PATIENT'S DOCTOR FOUND THAT THE EMBOLIZATION COILS "ERODED INTO THE MOST GONADAL VEIL INTO THE URETER." ON OR ABOUT (B)(6) 2019, THE PATIENT HAD THE COILS REMOVED DUE TO "CHRONIC PELVIC AND ABDOMINAL PAIN." AFTER THE COILS WERE REMOVED, THE PATIENT BEGAN TO FEEL RELIEF. MEDICAL RECORDS INDICATED THE FOLLOWING: ON (B)(6) 2018, THE PATIENT UNDERWENT SOTRADECOL EMBOLIZATION OF PELVIC VEIN VARICOSITIES AND A COIL AND GELFOAM EMBOLIZATION OF THE LEFT CANAL VEIN DUE TO SEVERE PELVIC PAIN WITH A MARKEDLY DILATED LEFT GONADAL VEIN. AN ULTRASOUND WAS UTILIZED TO EVALUATE THE RIGHT

  Patient problems: Nerve Damage; No Code Available; Pain

  MAUDE report 11223057 ↗
• MalfunctionJul 29, 2020Difficult to Advance; Difficult to Advance

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10337362 ↗
• 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 9538211 ↗
• 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 9537834 ↗
• InjuryDec 31, 2019Migration; Migration

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

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9536211 ↗
• MalfunctionSep 19, 2019Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED A NESTER PLATINUM EMBOLIZATION COIL WAS TO BE USED IN A MALE PATIENT FOR AN EMBOLIZATION PROCEDURE. WHILE ATTEMPTING TO INSERT THE FIFTH COIL, THE PHYSICIAN ¿MET RESISTANCE¿ AND THE COIL COULD NOT BE PUSHED OUT. THE PHYSICIAN THEN REMOVED THE DEVICE AND ¿TRIED MANY TIMES TO PUSH THE COIL STRONGLY,¿ AND FINALLY THE COIL WAS PUSHED OUT. THE DEVICE WAS REPLACED WITH A NEW SIMILAR DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. DURING THE DEVICE FAILURE ANALYSIS COMPLETED ON THE 21 AUG 2019, IT WAS DETERMINED THAT THE COIL HAD SEPARATED INTO TWO SECTIONS. THE COMPLAINT WAS DETERMINED TO BE REPORTABLE ON THIS DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086111 ↗
• InjuryApr 6, 2016Unraveled Material; Unraveled Material

  DURING A VARICOCELE EMBOLIZATION TO SPERMADIC VEIN PROCEDURE ON THE (B)(6) YEAR OLD MALE PATIENT, THE COIL UNRAVELED INSIDE THE VEIN AND PARTS OF IT ENDED IN THE RENAL VEIN. THE IR HAD TO USE VASCULAR RETRIEVAL FORCEPS TO REMOVE THE PARTS OF THE COIL. NO PIECE OF THE DEVICE REMAINED IN THE PATIENT'S BODY. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5550828 ↗