Exacta™ 27636Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000333492), received between Sep 13, 2023 and Sep 14, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. Nov 1, 2024Open, Classified

   Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

   Z-0662-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE CSF DRAINAGE DID NOT DRIP, THE REPORTER PERHAPS THERE WAS A PROBLEM WITH THE AIR IN THE PRODUCT. AFTER THE SURGEON FINISHED PERFORMING THE SURGERY THE DRAINAGE SYSTEM (THE LINE DOWN TO THE DRAINAGE BAG WAS CLOSING) THE FLUID DID NOT DRAIN INTO THE DRIP CHAMBER UNTIL HE OPENED THE LINE DOWN TO THE BAG BY TURNING THE STOPCOCK .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744322 ↗
• MalfunctionSep 14, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE CSF DRAINAGE DID NOT DRIP, THE REPORTER PERHAPS THERE WAS A PROBLEM WITH THE AIR IN THE PRODUCT. AFTER THE SURGEON FINISHED PERFORMING THE SURGERY THE DRAINAGE SYSTEM (THE LINE DOWN TO THE DRAINAGE BAG WAS CLOSING) THE FLUID DID NOT DRAIN INTO THE DRIP CHAMBER UNTIL HE OPENED THE LINE DOWN TO THE BAG BY TURNING THE STOPCOCK .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744299 ↗
• MalfunctionSep 14, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE CSF (CEREBROSPINAL FLUID) DRAINAGE DID NOT DRIP, PERHAPS THERE WAS A PROBLEM WITH THE AIR IN THE PRODUCT. AFTER THE SURGEON FINISHED PERFORMING THE SURGERY, THE DRAINAGE SYSTEM (THE LINE DOWN TO THE DRAINAGE BAG WAS CLOSING) THE FLUID DID NOT DRAIN INTO THE DRIP CHAMBER UNTIL THEY OPENED THE LINE DOWN TO THE BAG BY TURNING THE STOPCOCK. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744177 ↗
• MalfunctionSep 14, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE CSF (CEREBROSPINAL FLUID) DRAINAGE DID NOT DRIP, PERHAPS THERE WAS A PROBLEM WITH THE AIR IN THE PRODUCT. AFTER THE SURGEON FINISHED PERFORMING THE SURGERY, THE DRAINAGE SYSTEM (THE LINE DOWN TO THE DRAINAGE BAG WAS CLOSING) THE FLUID DID NOT DRAIN INTO THE DRIP CHAMBER UNTIL THEY OPENED THE LINE DOWN TO THE BAG BY TURNING THE STOPCOCK. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744092 ↗
• MalfunctionSep 13, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE CEREBROSPINAL FLUID (CSF) DID NOT FLOW. ONLY A LITTLE CSF FLOWED WHEN THE SYSTEM WAS SET VERY LOW. THE FLUID ALSO DID NOT FLOW INTO THE BAG EVEN THOUGH THE STOPCOCK WAS OPENED. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17735987 ↗