Cortoss 2101-0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00808232000979), received between Aug 9, 2018 and Aug 9, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 1, 2020Terminated

   Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.

   Z-1900-2020 · Root cause: Storage · FDA record ↗

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 9, 2018Leak/Splash; Migration or Expulsion of Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A PATIENT¿S BONE BECAUSE IT WAS BROKEN, CORTOSS WAS BEING INJECTED AT THE L5 LEVEL WHEN IT MIGRATED INTO THE PATIENT¿S HEART. THE LEAKAGE WAS NOTICED WITH FLUOROSCOPY. THE PROCEDURE ENDED EARLY AND THE PATIENT WAS PUT ON SHORT TERM ANTI-COAGULANTS. THE REPRESENTATIVE NOTED THE MATERIAL HAD MIGRATED INTO A VEIN WHEN THE DOCTOR WAS TRYING TO PUT A NEEDLE IN THE OTHER SIDE, AND THE BONE HE WAS HAMMERING THE NEEDLE ON WAS SO HARD IT CAUSED THE MATERIAL TO JIGGLE LOOSE. IT WAS NOTED THERE WERE NO ISSUE WITH THE CORTOSS MATERIAL DURING THE PROCEDURE.

  Patient problems: Embolism; Foreign Body In Patient

  MAUDE report 7770534 ↗