Nester G52751Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002527515), received between Jan 2, 2020 and Jul 19, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (3 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.

• MalfunctionJul 19, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ADDITIONAL INFORMATION WAS PROVIDED ON 21JUL2021 WHICH INDICATED THE PHYSICIAN "HAD NO CHOICE" AND USED AN OVERSIZED COIL FOR EMBOLIZATION OF THE RENAL ARTERY PRIOR TO KIDNEY SURGERY. THE RADIOLOGIST "STARTED PULLING OUT THE COIL IN THE VESSEL" AND EXPERIENCED "BAD DEPLOYMENT." THE COIL WAS "RETRIEVED WITH THE SELECTIVE CATHETER." ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

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

  MAUDE report 12193277 ↗
• InjuryJan 18, 2021Migration; 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 11186987 ↗
• 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 9538430 ↗
• 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 9538272 ↗