Neoss Implant System 64082Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060440335556), received between Aug 21, 2024 and Aug 21, 2024 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT DEVELOPED A MAJOR BLEED FOLLOWING RADIO FREQUENCY ABLATION TREATMENT ON THE (B)(6) PRESENTED TO HOSPITAL WITH C/O VOMITING BLOOD (ABOUT 1 PINT) A WEEK AFTER HAVING HALOTHERAPY. ALSO, C/O FEELING SHORT OF BREATH AND BEING NAUSEOUS, WITH SOME EPIGASTRIC PAIN, AND HAVING BLACK STOOLS. ON EXAMINATION HE WAS QUITE PALE, AND HEMODYNAMICALLY UNSTABLE. PATIENT WAS RESUSCITATED WITH BLOOD AND PLASMA TRANSFUSION AND WAS TREATED WITH IV PPI AND WAS TAKEN FOR URGENT OGD, WHICH SHOWED A LARGE UGI BLEED SECONDARY TO ULCER, AND WAS ENDO-CLIPPED. TWO DAYS POST-OPERATIVE, THE PATIENT WAS ADMITTED TO A LOCAL HOSPITAL¿S INTENSIVE THERAPY UNIT WITH A MAJOR BLEED. THE PATIENT UNDERWENT ANOTHER RADIO FREQUENCY ABLATION ON THE (B)(6) TO TREAT (B)(6) OESOPHAGUS AND DEVELOPED ANOTHER MAJOR BLEED ON THE (B)(6), LEADING TO ANOTHER HOSPITAL ADMISSION. AS OF THE (B)(6), THE PATIENT WAS STILL IN THE INTENSIVE THERAPY UNIT. NOTHING ABNORMAL WAS NOTED DURING THE RADIO FREQUENCY ABLATION OR IMMEDIATELY AFTER THE PROCEDURE. A NEW CATHETER WAS USED FOR EACH ABLATION. THE TECHNIQUE USED TO ABLATE THE TISSUE WAS (B)(6) 2024 C10 M10 30-40 CM TREATED WITH CIRCUMFERENTIAL (APP, SCRA

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vomiting

  MAUDE report 20012315 ↗