ExactaRecalls & reported problems across all models
Medtronic Ps Medical, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Exacta model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 438
- Deaths reported
- 2
- Injuries reported
- 20
- Recalls
- 1
We found 12 models of Exacta by Medtronic Ps Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 438 adverse event reports in the FDA's MAUDE database, received between Feb 7, 2017 and Apr 23, 2026 — classified as 2 deaths, 20 injuries, 416 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (379 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Exacta recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 9 of these models · Recall details · FDA record ↗
Most reported Exacta problems
Device problems
- Fluid/Blood Leak379
- Break65
- Fracture62
- Disconnection16
- Complete Blockage11
- Leak/Splash7
- Infusion or Flow Problem3
- Device Operates Differently Than Expected2
Patient problems
- No Clinical Signs, Symptoms or Conditions406
- No Known Impact Or Consequence To Patient21
- Unspecified Tissue Injury7
- Unspecified Infection3
- Coma2
- Fever2
- No Code Available2
- No Consequences Or Impact To Patient2
Exacta models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Exacta™ 46700Shunt, central nervous system and components1 recall2 deaths163 reports
- Exacta™ 27666Device, monitoring, intracranial pressure1 recall124 reports
- Exacta™ 46705Device, monitoring, intracranial pressure1 recall117 reports
- Exacta™ 27636Device, monitoring, intracranial pressure1 recall5 reports
- Exacta™ 27732Shunt, central nervous system and components1 recall1 report
- Exacta™ 27581Device, monitoring, intracranial pressure1 recall0 reports
- Exacta™ 27785Shunt, central nervous system and components1 recall0 reports
- Exacta™ 27795Device, monitoring, intracranial pressure1 recall0 reports
- Exacta™ 27861Device, monitoring, intracranial pressure1 recall0 reports
- Exacta™ 46700DEVICE, MONITORING, INTRACRANIAL PRESSURE23 reports
- Exacta™ 46700DEVICE, MONITORING, INTRACRANIAL PRESSURE3 reports
- Exacta™ 46710Shunt, central nervous system and components2 reports
Recent Exacta adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗
Other Medtronic Ps Medical, Inc. products
All Medtronic Ps Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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