Nester G52756Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002527560), received between Jan 25, 2021 and Apr 6, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Expulsion” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Expulsion

  IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION COIL ERODED THROUGH A VESSEL WALL. THE COIL WAS PLACED ON AN UNKNOWN DATE DURING A BRTO [BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION] PROCEDURE FOR THE TREATMENT OF GASTRIC VARICES. THE TARGET SITE WAS A GASTRIC VARIX WHICH, "BASED ON THE COIL SIZE, WAS ESTIMATED TO BE =18 MM. HOWEVER, IT WAS SOFT AND HAD AN IRREGULAR, NODULAR APPEARANCE, SUGGESTIVE OF A CONGLOMERATION OF VARICES." ACCORDING TO THE USER, NO RESISTANCE OR OTHER ISSUES WERE NOTED UPON DEPLOYMENT OF THE COIL. SEVERAL MONTHS AFTER THE COIL PLACEMENT, ENDOSCOPY REVEALED THAT THE COIL HAD PROTRUDED INTO THE STOMACH. THE PATIENT IS CURRENTLY UNDER OBSERVATION. THE TREATMENT TEAM IS CONSIDERING WHETHER THE COIL SHOULD BE CUT AND IS CONSIDERING POSSIBLE COMPLICATIONS THAT COULD OCCUR RELATED TO ITS EXPOSURE IN THE STOMACH. NO PATIENT SYMPTOMS ARE PRESENT AT THIS TIME. ON (B)(6) 2026, THE COOK SALES REPRESENTATIVE VISITED THE PHYSICIAN AND REVIEWED PHOTOGRAPHS, WHICH SHOWED APPROXIMATELY 5 TO 7 CM OF COIL PROTRUDING FROM TWO LOCATIONS. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. AN ADDITIONAL COIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793073 ↗
• MalfunctionApr 6, 2026Expulsion

  IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION COIL ERODED THROUGH A VESSEL WALL. THE COIL WAS PLACED ON AN UNKNOWN DATE DURING A BRTO [BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION] PROCEDURE FOR THE TREATMENT OF GASTRIC VARICES. THE TARGET SITE WAS A GASTRIC VARIX WHICH, "BASED ON THE COIL SIZE, WAS ESTIMATED TO BE =18 MM. HOWEVER, IT WAS SOFT AND HAD AN IRREGULAR, NODULAR APPEARANCE, SUGGESTIVE OF A CONGLOMERATION OF VARICES." ACCORDING TO THE USER, NO RESISTANCE OR OTHER ISSUES WERE NOTED UPON DEPLOYMENT OF THE COIL. SEVERAL MONTHS AFTER THE COIL PLACEMENT, ENDOSCOPY REVEALED THAT THE COIL HAD PROTRUDED INTO THE STOMACH. THE PATIENT IS CURRENTLY UNDER OBSERVATION. THE TREATMENT TEAM IS CONSIDERING WHETHER THE COIL SHOULD BE CUT AND IS CONSIDERING POSSIBLE COMPLICATIONS THAT COULD OCCUR RELATED TO ITS EXPOSURE IN THE STOMACH. NO PATIENT SYMPTOMS ARE PRESENT AT THIS TIME. ON 31MAR2026, THE COOK SALES REPRESENTATIVE VISITED THE PHYSICIAN AND REVIEWED PHOTOGRAPHS, WHICH SHOWED APPROXIMATELY 5 TO 7CM OF COIL PROTRUDING FROM TWO LOCATIONS. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. AN ADDITIONAL COIL FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793056 ↗
• InjuryJan 25, 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 DISCOVERED THAT CONTAINED WITHIN A SPREADSHEET SUPPLIED BY THE PATIENT'S LEGAL TEAM WAS A STATEMENT ALLEGING THE FOLLOWING: "COILS WERE REMOVED BECAUSE THEY CAUSE CAUSED THE PAIN AND PERFORATED THE RENAL VEIN WHICH WAS THE CAUSE OF THE KIDNEY PAIN; DENERVATION AND STRIPPING OF LEFT RENAL VEIN." NO OTHER DETAILS REGARDING THIS OCCURRENCE ARE AVAILABLE AT THIS TIME.

  Patient problems: Abdominal Pain; Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 11223846 ↗