Exacta™ 46700 (UDI 00643169707665)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169707665), received between Jun 7, 2017 and May 27, 2021 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS CONNECTED TO THE CEREBRAL VENTRICLE DRAINAGE CATHETER ON (B)(6) 2021, AND A CRACK IN THE CATHETER WAS FOUND ON THE NIGHT OF (B)(6) 2021. THE DRAINAGE CATHETER WAS CLAMPED IMMEDIATELY AND THEN REMOVED THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894073 ↗
• MalfunctionJul 7, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE PATIENT RETURNED TO THE WARD AFTER THE SURGERY, IT WAS FOUND THAT THE THREE WAY VALVE OF THE EXTERNAL DRAINAGE MAIN SYSTEM LEAKED. THE PATIENT'S CURRENT STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10240285 ↗
• MalfunctionJul 4, 2020Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE CRACK IN THE DEVICE WAS NOT DETERMINED. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10230989 ↗
• MalfunctionMay 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE VALVE BELOW THE DRAINAGE BAG COULD NOT BE SCREWED TIGHT, AND IT WOULD ALWAYS DRIP AND LEAK CEREBROSPINAL FLUID. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO CHEMICALS OF ANY TYPE WERE USED FOR CLEANING THE CONNECTIONS. IT WAS ALSO STATED THAT THERE WAS NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10066622 ↗
• InjuryMar 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT LINE STOPCOCK HAD THE ISSUE. THE CHEMICAL USED FOR CLEANING ALL THE CONNECTIONS WAS IODIDE DISINFECTANT. NO TOOL WAS USED TO TWIST/BEND THE PATIENT LINE THAT MIGHT HAVE LED TO THE CRACKED CONNECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9869358 ↗
• InjuryMar 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT LINE STOPCOCK HAD THE ISSUE. THE CHEMICAL USED FOR CLEANING ALL THE CONNECTIONS WAS IODIDE DISINFECTANT. NO TOOL WAS USED TO TWIST/BEND THE PATIENT LINE THAT MIGHT HAVE LED TO THE CRACKED CONNECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9869292 ↗
• MalfunctionNov 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTERNAL DRAINAGE OF THE LUMBAR CISTERN. WHEN THE EXTERNAL DRAINAGE WAS CONNECTED, IT WAS FOUND THAT THE THREE-WAY VALVE OF THE EXTERNAL DRAINAGE BAG WAS LEAKING. THE EXTERNAL DRAINAGE WAS REPLACED WITH A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9349227 ↗
• MalfunctionSep 11, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE DEVICE WAS PLACED, THE DOCTOR FOUND THAT THE THREE-WAY VALVE WAS CRACKED AND LEAKING. THE DEVICE WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS WAS ALIVE - NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8994590 ↗
• MalfunctionApr 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE LEAKAGE OCCURRED IN THE WARD. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8518981 ↗
• MalfunctionApr 10, 2019Break; Disconnection; Fracture; Device Damaged Prior to Receipt by User; Break; Disconnection; Fracture; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED REGARDING A PATIENT UNDERGOING DRILLING AND DRAINAGE SURGERY FOR TREATMENT OF A CHRONIC SUBDURAL HEMATOMA. IT WAS REPORTED THAT, AFTER OPENING THE PACKAGE WHEN THE DOCTOR GRABBED THE TIP OF THE DRAINAGE SYSTEM AND CONNECTED IT TO THE TIP OF THE CATHETER, THE DRAINAGE SYSTEM ANTI-PRESSURE TUBE AND TEE SHUNT IN THE PATIENT'S END FELL OFF, CAUSING IT TO BE CONTAMINATED. AS A RESULT THE DEVICE WAS REPLACED. THE DEVICE DID NOT HAVE CONTACT WITH THE PATIENT, BUT RESULTED IN A 10 MINUTE EXTENDED SURGERY TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8500818 ↗
• MalfunctionDec 17, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE DRAINAGE OF THE PATIENT, THE CEREBROSPINAL FLUID WAS BLOCKED IN THE CHAMBER AND COULD NOT FLOW INTO THE DRAINAGE BAG. THE PRODUCT WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8171522 ↗
• MalfunctionOct 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2018, THE DOCTOR USED THE DEVICE IN VITRO MONITORING SYSTEM IN AN EXTRAVENTRICULAR DRAINAGE. WHEN IT WAS CONNECTED TO THE VENTRICLE CATHETER, THE DEVICE WAS FOUND TO HAVE LEAKAGE AND AIR COUNTER FLOW. THE DOCTOR IMMEDIATELY CHANGED THE DEVICE TO A NEW ONE. THE DEVICE OPERATION PROCEEDED SMOOTHLY, AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8014551 ↗
• MalfunctionAug 9, 2018Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak

  IT WAS REPORTED THAT THE 3 WAY ADAPTER LEAKED AND COULDN'T BE TIGHTENED. IT WAS NOTED THAT THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE - NO INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7767845 ↗
• MalfunctionAug 9, 2018Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak

  IT WAS REPORTED THAT THE 3 WAY ADAPTER LEAKED AND COULDN'T BE TIGHTENED. IT WAS NOTED THAT THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7767811 ↗
• MalfunctionJun 18, 2018Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DOCTOR DISCOVERED "THE TUBE WALL EXTERNAL DRAINAGE AND MONITORING SYSTEM HAD ITS OWN CLEFT" DURING THE IMPLANTATION OF THE MATERIAL. THE PRODUCT WAS REPLACED AND THE PATIENT'S STATUS WAS ALIVE-NO INJURY. IT WAS FURTHER CLARIFIED THAT THE WALL OF THE PIPE OF THE EXTERNAL DRAINAGE AND MONITORING SYSTEM HAD A RIFT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7610791 ↗
• InjuryMay 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT BEING UNCONSCIOUS WAS NOT RELATED TO THE DEVICE. THIS WAS DUE TO THE PATIENT¿S HISTORY OF TRAUMA. IT WAS STATED THE LEAKING OCCURRED AT THE MAIN SYSTEM STOPCOCK.

  Patient problems: Coma; No Known Impact Or Consequence To Patient

  MAUDE report 7480801 ↗
• MalfunctionNov 27, 2017Disconnection; Disconnection

  IT WAS REPORTED THE PATIENT UNDERWENT CEREBROSPINAL DRAINAGE SURGERY. DURING THE PROCEDURE, IT WAS FOUND THAT THE DEVICE ¿EASILY FELL OFF NEAR THE EFFUSION CHAMBER.¿ THE DEVICE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7061957 ↗
• MalfunctionSep 21, 2017Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAKAGE OCCURRED AT THE "JOINT." THE CAUSE OF THE LEAKAGE WAS NOT DETERMINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6883755 ↗
• MalfunctionSep 21, 2017Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAKAGE OCCURRED AT THE "JOINT." THE CAUSE OF THE LEAKAGE WAS NOT DETERMINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6882759 ↗
• MalfunctionJun 29, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER A VENTRICULAR DRAINAGE SURGERY, IN THE COURSE OF OBSERVING THE PATIENT'S CONDITION, THE PHYSICIAN FOUND THAT THERE WAS GAS IN THE PATIENT'S LATERAL VENTRICLE DUE TO THE DRAIN PIPE LEAKING ON (B)(6) 2017. ACCORDING TO THE REPORT, THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER DEVICE. REPORTEDLY, THE PATIENT'S STATUS AT THE TIME OF THE REPORT ALIVE-NO INJURY.

  Patient problems: No Code Available

  MAUDE report 6677889 ↗
• MalfunctionJun 21, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE JOINTS HAD CRACKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6657966 ↗
• MalfunctionJun 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DISEASE THAT WAS EXPECTED TO BE TREATED WAS CEREBRAL HEMORRHAGE. ACCORDING TO THE REPORT, THE PATIENT HAD INTRAVENTRICULAR DRAINAGE SURGERY, AND THE DOCTOR "COULD NOT LEAD THE BLOOD." REPORTEDLY, THE DOCTOR HAD TO REPLACE WITH A NEW ONE TO COMPLETE THE SURGERY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6648354 ↗
• MalfunctionJun 7, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT'S PRIMARY DISEASE WAS CRANIOCEREBRAL TRAUMA. ACCORDING TO THE REPORT, PO ST-OPERATIVE OBSERVATION FOUND LEAKAGE OF THE ¿DRAINAGE TUBE¿ CAUSING THE PATIENT'S VENTRICLE TO BECOME A "CAVITY." REPORTEDLY, THE PHYSICIAN REPLACED WITH A NEW ¿TUBE,¿ AND THE PATIENT'S CURRENT STATUS WAS NORMAL.

  Patient problems: No Code Available

  MAUDE report 6620895 ↗