Exacta™ 46705Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00763000333706), received between Oct 14, 2022 and Apr 23, 2026 — classified as 3 injuries, 114 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (109 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) , 2026, WHILE THE PATIENT WAS USING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM, THE NURSE FOUND THAT THE THREE-WAY CONNECTING TUBE HAD BECOME DISCONNECTED. THE EXTERNAL DRAINAGE MONITORING SYSTEM WAS IMMEDIATELY REPLACED WITH A NEW ONE. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967296 ↗
• MalfunctionApr 7, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2026, AFTER THE DEVICE HAD BEEN USED FOR EXTERNAL VENTRICULAR DRAINAGE FOR 2 HOURS ON PATIENT, RUPTURE WITH BLOOD OOZING WAS OBSERVED AT THE VENTRICULAR-END CONNECTION INTERFACE OF THE DEVICE. THEREFORE, A NEW DEVICE WAS USED INSTEAD AND CONNECTED TO CONTINUE DRAINAGE. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-WITH INJURY AS THE PATIENT HAD HYDROCEPHALUS, WHICH WAS NOT CAUSED BY THE DEVICE USED IN THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799258 ↗
• MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER THE PATIENT'S CEREBRAL HEMORRHAGE SURGERY, IT WAS FOUND THAT WHEN COLLECTING CEREBROSPINAL FLUID SAMPLES, IT WAS FOUND THAT AIR WAS ENTERING THE THREE-WAY VALVE OF THE DRAINAGE SYSTEM AND THERE WAS LOCAL LIQUID LEAKAGE. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053970 ↗
• MalfunctionDec 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A CEREBRAL HEMORRHAGE. AFTER THE OPERATION, THE DOCTOR PERFORMED DRAINAGE AND FOUND THE DEVICE WAS LEAKING AT THE THREE-WAY VALVE. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901367 ↗
• MalfunctionNov 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT UNDERWENT SKULL DEFECT REPAIR. THE DRAINAGE TUBE WAS PLACED IN THE EPIDURAL SPACE, AND THE CONNECTOR OF THE DRAINAGE TUBE LEAKED AFTER THE OPERATION. THE DEVICE WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651444 ↗
• MalfunctionSep 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING THE SURGERY, THE DEVICE WAS OPENED FOR DRAINAGE, AND THERE WAS LEAKAGE/BLOOD OOZED WHERE THE DRAINAGE PASSED THROUGH THE VALVE. THE DEVICE WAS REPLACED WITH A NEW SET. THERE WAS A DELAY IN THE PROCEDURE OF 30 MINUTES. THE PATIENT'S MEDICAL HISTORY WAS MULTIPLE VENTRICULAR HEMORRHAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278384 ↗
• MalfunctionSep 4, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE PATIENT WITH A CEREBRAL HEM ORRHAGE NEEDED TO HAVE A LUMBAR CISTERN DRAINAGE TUBE PLACED FOR CEREBROSPINAL FLUID DRAINAGE. ON (B)(6) 2024, SHORTLY AFTER THE PLACEMENT, LIQUID WAS FOUND TO BE LEAKING FROM THE THREE-WAY JOINT CONNECTED TO THE DRAINAGE BAG, AND THE DOCTOR WAS IMMEDIATELY INFORMED. AFTER ASSISTING THE DOCTOR IN DISINFECTION, OBSERVED THAT THERE WAS CRACK ON THE THREE-WAY AND LIQUID WAS CONSTANTLY SEEPING OUT, SO REPLACED IT. SO FAR, IT DID NOT AFFECT THE PATIENT, AND THE DRAINAGE WAS SMOOTH AFTER THE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134979 ↗
• MalfunctionAug 27, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT AFTER THE OPERATION, WHEN USING THE DEVICE FOR DRAINAGE, THE MAIN SYSTEM THREE-WAY WAS BROKEN AND LEAKED. THE DEVICE WAS REPLACED WITH A NEW SYSTEM. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075234 ↗
• MalfunctionJul 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THAT THE AFTER CONNECTING THE PATIENT TO THE VENTRICULAR DRAINAGE DEVICE, THERE AS LEAKAGE FOUND AT THE INTERFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19841342 ↗
• MalfunctionJul 8, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON MARCH 21, 2024, THE PATIENT HAD A SUBDURAL EFFUSION AND UNDERWENT EXTERNAL DRAINAGE SURGERY. DURING THE INTRAOPERATIVE TEST, THE THREE-WAY VALVE JOINT WAS FOUND TO BE CRACKED AND LEAKING. THE DOCTOR REPLACED IT WITH A NEW ONE FOR THE SURGERY. THERE WAS A PROCEDURE DELAY OF 20 MINUTES. THE PATIENT'S STATUS WAS ALIVE-WITH INJURY AS THE PATIENT HAD A SUBDUAL EFFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688686 ↗
• MalfunctionJul 8, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6), 2024, THE PATIENT DEVELOPED A SUBDURAL EFFUSION AND UNDERWENT EXTERNAL DRAINAGE SURGERY. DURING THE OPERATION, THE THREE-WAY VALVE JOINT WAS TESTED AND FOUND TO BE CRACKED AND LEAKING LIQUID. THE DOCTOR REPLACED IT WITH A NEW ONE FOR THE OPERATION. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS WAS ALIVE-WITH INJURY AS THE PATIENT HAD A SUBDURAL EFFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688559 ↗
• MalfunctionJun 26, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT HAD A SUBDURAL EFFUSION AND UNDERWENT EXTERNAL DRAINAGE SURGERY. DURING THE OPERATION, THE THREE-WAY VALVE JOINT WAS TESTED AND FOUND TO BE CRACKED AND LEAKING. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-WITH INJURY AS THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO SUDDEN DIZZINESS, HEADACHE, NAUSEA AND VOMITING FOR 2 DAYS. EMERGENCY HEAD CT SHOWED: LEFT OCCIPITAL LOBE HEMORRHAGE. PHYSICAL EXAMINATION UPON ADMISSION: THE PATIENT WAS CONFUSED AND IN VERY POOR SPIRITS. THE PUPILS ON BOTH SIDES WERE EQUAL IN SIZE AND ROUND, WITH THE LEFT TO RIGHT = 4:4 MM. THE PATIENT HAD A SLOW LIGHT REFLEX, IRRELEVANT QUESTIONS AND ANSWERS, WAS IRRITABLE, DID NOT COOPERATE WITH THE PHYSICAL EXAMINATION, WAS IN A PASSIVE POSITION, AND WAS PUSHED INTO THE WARD ON A CART. THE RIGHT LIMB MUSCLE STRENGTH WAS LEVEL 2, THE LEFT LIMB MUSCLE STRENGTH WAS LEVEL 4, THE LEFT PATHOLOGICAL SIGNS WERE POSITIVE, AND THE RIGHT WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614443 ↗
• MalfunctionJun 26, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT HAD A SUBDURAL EFFUSION AND UNDERWENT EXTERNAL DRAINAGE SURGERY. DURING THE OPERATION, THE THREE-WAY VALVE JOINT WAS TESTED AND FOUND TO BE CRACKED AND LEAKING. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-WITH INJURY AS THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "SUDDEN UNCONSCIOUSNESS FOR 8 HOURS". AFTER ADMISSION, AN EMERGENCY HEAD CT SCAN SHOWED THAT THE RIGHT THALAMUS HAD HEMORRHAGE AND HAD BROKEN INTO THE VENTRICLE. THE PATIENT WAS IN A CRITICAL CONDITION AND IN A DEEP COMA. AFTER THE OPERATION, THE INTRACRANIAL HEMATOMA WAS BASICALLY DRAINED, THE PATIENT WAS CONSCIOUS, THEIR CONSCIOUSNESS WAS RESTORED, THEIR QUESTIONS AND ANSWERS WERE RELEVANT, THEIR LIMBS HAD NORMAL MUSCLE STRENGTH, AND THEY FOLLOWED THE DOCTOR'S INSTRUCTIONS TO MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614381 ↗
• MalfunctionMay 15, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED ON (B)(6) 2024, THE DEVICE WAS USED ON THE PATIENT 24-HOUR CONTINUOUS CEREBROSPINAL FLUID DRAINAGE. ON (B)(6) 2024, BOTH ENDS OF THE THREE-WAY OF THE PATIENT'S EXTERNAL VENTRICULAR DRAINAGE TUBE FELL OFF. AS A RESULT, THE DRAINAGE TUBE AND DRAINAGE BAG WERE REPLACED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319959 ↗
• MalfunctionApr 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  2024-APR-16 N/A (HCP): MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE THERE WAS A LEAK A IN THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143444 ↗
• MalfunctionMar 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2024, AFTER THE CONNECTION DURING THE SURGERY, LEAKAGE WAS FOUND AT THE TEE-JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002649 ↗
• InjuryFeb 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S INJURY WAS NOT SERIOUS, AND THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18776769 ↗
• MalfunctionFeb 22, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING THE SURGERY, CRACKS WERE FOUND ON THE LIQUID COLLECTION CAVITY AFTER UNPACKING IT. THE PRODUCT WAS REPLACED. THERE WAS A DELAY IN THE PROCEDURE OF 20 MINUTES. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757457 ↗
• MalfunctionNov 27, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING USE, LIQUID LEAKAGE OCCURRED/CRACK APPEARED IN THE LIQUID COLLECTION CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211332 ↗
• MalfunctionNov 27, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXACTA DRAINAGE DEVICE. IT WAS REPORTED THAT THE PATIENT SUFFERED "UNCONSCIOUSNESS FOR MORE THAN 1 HOUR", AND THEY WERE ADMITTED TO OUR DEPARTMENT IN EMERGENCY AT 00:22 ON (B)(6) 2023. AFTER COMPLETING RELEVANT EXAMINATIONS AND PREOPERATIVE PREPARATIONS, BILATERAL EXTERNAL VENTRICULAR DRILLING AND DRAINAGE SURGERY WAS PERFORMED UNDER GENERAL ANESTHESIA WITH INTUBATION IN THE OPERATING ROOM. AT TWO O'CLOCK IN THE AFTERNOON ON (B)(6) 2023, THE NURSE FOUND CRACKS IN THE DROPPER BOTTLE WHEN POURING THE DRAINAGE FLUID. IMMEDIATELY REPORTED TO THE DOCTOR AND HEAD NURSE ON DUTY AND REPLACED THE EXTERNAL DRAINAGE AND MONITORING SYSTEM IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210772 ↗
• MalfunctionNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS EVENT WAS REPORTED IN ERROR AS THE CUSTOMER CLARIFIED THE QUANTITY OF AFFECTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161650 ↗
• MalfunctionNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161566 ↗
• MalfunctionNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161522 ↗
• MalfunctionNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161491 ↗
• MalfunctionNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS EVENT WAS REPORTED IN ERROR AS THE CUSTOMER CLARIFIED THE QUANTITY OF AFFECTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161378 ↗