Exacta™ 46700 (UDI 00763000333690)Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 00763000333690), received between Jan 6, 2021 and Mar 31, 2026 — classified as 2 deaths, 14 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (135 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 25 most recent of 163 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING NORMAL POST-OPERATIVE USE OF THE EXTERNAL VENTRICULAR DRAINAGE SYSTEM, THE PHYSICIAN IDENTIFIED A RUPTURE OF THE COLLECTION CHAMBER OF THE DEVICE. THE DEVICE WAS REPLACED WITH A NEW ONE TO CONTINUE DRAINAGE FOR THE PATIENT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS INTRACRANIAL MASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742440 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON POST-OPERATIVE DAY 4 OF EXTERNAL VENTRICULAR DRAINAGE, FLUID LEAKAGE WAS NOTED FROM THE THREE-WAY STOPCOCK OF THE EXTERNAL DRAINAGE BAG. THE DEVICE WAS REPLACED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711399 ↗
• MalfunctionMar 20, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHILE THE PATIENT WAS UNDERGOING NORMAL DRAINAGE, A NURSE ON ROUNDS DISCOVERED A CRACK IN THE COLLECTION CHAMBER; DEEMING THIS TO POSE AN INFECTION RISK, IT WAS SUBSEQUENTLY REPLACED WITH A NEW SET TO CONTINUE DRAINAGE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647790 ↗
• MalfunctionDec 29, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT UPON OPENING THE PACKAGE, A CRACK WAS FOUND IN THE PRODUCT, SO IT WAS NOT USED AND REPLACED WITH A NEW PRODUCT FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905129 ↗
• MalfunctionDec 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT LIQUID LEAKAGE AT THE THREE-WAY CONNECTOR WAS NOTICED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887530 ↗
• MalfunctionDec 24, 2025Fluid/Blood Leak; Component Missing; Fluid/Blood Leak; Component Missing

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CONNECTOR WAS LOST, AND THIS OCCURRED DURING THE PROCEDURE. THE ISSUE WAS DISCOVERED UPON OPENING THE PACKAGING. THE PRODUCT DID NOT COME INTO CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887492 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE FOUND IN THE EXTERNAL VENTRICULAR DRAIN BACK DURING USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830539 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE FOUND IN THE EXTERNAL VENTRICULAR DRAIN BACK DURING USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830537 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE FOUND IN THE EXTERNAL VENTRICULAR DRAIN BACK DURING USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830516 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE FOUND IN THE EXTERNAL VENTRICULAR DRAIN BACK DURING USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830510 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE FOUND IN THE EXTERNAL VENTRICULAR DRAIN BACK DURING USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829652 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE FOUND IN THE EXTERNAL VENTRICULAR DRAIN BACK DURING USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829642 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE FOUND IN THE EXTERNAL VENTRICULAR DRAIN BACK DURING USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829621 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE FOUND IN THE EXTERNAL VENTRICULAR DRAIN BACK DURING USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829618 ↗
• MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE WAS FOUND TO HAVE LEAKAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741843 ↗
• MalfunctionNov 13, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED DURING USE OF THE REPORTED PRODUCT, A RUPTURE OCCURRED AT THE CONNECTION OF THE TUBE WALL, RESULTING IN LEAKAGE. THE PRODUCT 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 23542537 ↗
• MalfunctionNov 13, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED DURING USE OF THE REPORTED PRODUCT, A RUPTURE OCCURRED AT THE CONNECTION OF THE TUBE WALL, RESULTING IN LEAKAGE. THE PRODUCT 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 23542524 ↗
• MalfunctionNov 13, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED DURING USE OF THE REPORTED PRODUCT, A RUPTURE OCCURRED AT THE CONNECTION OF THE TUBE WALL, RESULTING IN LEAKAGE. THE PRODUCT 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 23542490 ↗
• MalfunctionOct 28, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE THREE-WAY VALVE LEAKED LIQUID AS THE PRODUCT WAS DAMAGED. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS A PROCEDURE DELAY OF 10 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 23403242 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2025, DURING THE SURGERY, THE NEUROSURGEON DISCOVERED LEAKAGE WHILE USING THIS DRAINAGE MONITORING SYSTEM. THE SYSTEM WAS IMMEDIATELY REPLACED WITH ANOTHER UNIT OF THE SAME BRAND, WHICH FUNCTIONED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346921 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE USER WORRIED THAT THIS WAS A PROBLEM LOT WITH THE SYSTEM AS IT HAD LEAKAGE BEFORE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978184 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE USER WORRIED THAT THIS WAS A PROBLEM LOT WITH THE SYSTEM AS IT HAD LEAKAGE BEFORE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978084 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE USER WORRIED THAT THIS WAS A PROBLEM LOT WITH THE SYSTEM AS IT HAD LEAKAGE BEFORE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977947 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE USER WORRIED THAT THIS WAS A PROBLEM LOT WITH THE SYSTEM AS IT HAD LEAKAGE BEFORE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976851 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE USER WORRIED THAT THIS WAS A PROBLEM LOT WITH THE SYSTEM AS IT HAD LEAKAGE BEFORE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976816 ↗