ARESRecalls & reported problems across all models
Medtronic Ps Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 1
- Injuries reported
- 16
- Recalls
- 0
We found 3 models of ARES by Medtronic Ps Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Sep 17, 2025 — classified as 1 death, 16 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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. 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
Most reported ARES problems
Device problems
- Adverse Event Without Identified Device or Use Problem12
- Insufficient Device Problem Information5
- Appropriate Device Problem Term/Code Not Available3
- Break2
- Fracture2
- Migration2
- Complete Blockage1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Unspecified Infection8
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient4
- Abdominal Pain3
- Adhesion(s)2
- Blurred Vision2
- Fatigue2
- Headache2
ARES models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ARES™ 95001Shunt, central nervous system and components1 death17 reports
- ARES™ 91101Shunt, central nervous system and components5 reports
- ARES™ 93092Shunt, central nervous system and components5 reports
Recent ARES adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2025Migration; Migration
MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT HAD AN X-RAY WHERE THE CATHETER ACROSS THE NECK, CHEST, ABDOMEN, AND PELVIS WAS INTACT, TERMINATING IN THE RIGHT LOWER QUADRANT. THIS WAS A CHANGE NOTED OF THE CATHETER JUST LATERAL TO THE RIGHT L1 TRANSVERSE PROCESS. THIS WAS A CHANGE IN ORIENTATION AS COMPARED TO THE PRIOR SHUNT SURVEY. THERE WAS A NEW LOOP/POSSIBLE KINK OF THE TUBING. THE PATIENT HAD BEEN EXPERIENCING HEADACHES, AND LOCALIZED SWELLING, MASS AND LUMP ON THE HEAD. A CT SCAN WAS PERFORMED AS WELL WITH THE RESULTS STATING THAT THE VENTRICLE SIZE WAS UNCHANGED WITH THE VENTRICLES LARGELY DECOMPRESSED. NO MIDLINE SHIFT OR EXTRA-AXIAL FLUID COLLECTION WAS SEEN. RIGHT FRONTAL APPROACH SHUNT TUBE WAS ONCE AGAIN SEEN UNCHANGED IN POSITION COMPARED TO PRIOR EXAM. NO EVIDENCE OF ACUTE HEMORRHAGE. THERE WAS A FOCAL PROTRUSION OF SOFT TISSUE SCALP OVER THE RESERVOIR IN THE RIGHT FRONTAL REGION. THIS WAS MORE PRONOUNCED COMPARED TO PRIOR EXAM, BUT THERE WAS NO EVIDENCE OF MASS OR FLUID COLLECTION. DURING AN EMERGENCY DEPARTMENT VISIT FROM (B)(6) 2025, THE PATIENT HAD A CT HEAD SCAN WITH NO
Patient problems: Headache; Insufficient Information; Memory Loss/Impairment; Swelling/ Edema
MAUDE report 23077048 ↗MalfunctionSep 2, 2025Material Discolored; Material Discolored
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING A VENTRICULOPERITONEAL SHUNT PLACEMENT AND DURING THE SITE'S PREPARATION, WHEN THE CATHETER WAS SOAKED IN AN ANTIBIOTIC SOLUTION, THE SITE NOTICED ONE OF THE ENDS OF THE CATHETER STARTED TO TURN YELLOW. IT WAS CLARIFIED THAT IT WASN'T QUITE YELLOW BUT A RED. THE DISTAL PORTION DID NOT HAVE THE SAME DISCOLORATION. IT WAS UNKNOWN IF THE CATHETER CAME THAT WAY OR IF IT WAS BECAUSE IT WAS SOAKED IN VANCOMYCIN SALINE. THE SITE SWITCHED TO ANOTHER CATHETER AND WAS ABLE TO CONTINUE. THE SITUATION COULD NOT BE REPLICATED WITH THE NEW CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939480 ↗InjuryJul 7, 2025Infusion or Flow Problem; Infusion or Flow Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THE PATIENT WAS RECOVERING FROM A BRAIN TUMOR (MEDULLOBLASTOMA). IT WAS STATED THE DEVICE WAS EXTERNALIZED AS THE PATIENT WAS GOING THROUGH RADIOTHERAPY. THEY WERE GOING TO INTERNALIZE IT MAYBE ON (B)(6) 2025. THIS WAS CLARIFIED INDICATING THAT THE SHUNT WAS STILL IN PLACE AND THAT THE EXIT WAS OUT OF THE ABDOMEN TO A BAG. IT WAS INDICATED THE PATIENT HAD CEREBRAL MUTISM AND WAS UNABLE TO COMMUNICATE BUT SOMETIMES MAYBE SLIGHT HEAD NOD TO YES/NO QUESTIONS. THE PATIENT WAS ALSO HAVING PROBLEMS WITH OVER OR UNDER DRAINING AS THEY WERE HAVING SLIT VENTRICLES, THEN HUGE VENTRICLES. THEY HAVE NOT FOUND A DECENT DRAIN OPEN SCHEDULE. IT WAS INDICATED THAT THE PATIENT HAS HAD MULTIPLE POST OPERATIVE PROBLEMS. 10 WEEKS AFTER THE MEDULLOBLASTOMA WAS REMOVED, THE PATIENT WAS STILL MINIMALLY RESPONSIVE. EVERY CT SCAN SHOWED ENLARGED OR SLIT VENTRICLES. THE PATIENT NOW HAD MULTIPLE BLOOD CLOTS IN THEIR CEREBRAL VESSELS.
Patient problems: Thrombosis/Thrombus
MAUDE report 22418309 ↗MalfunctionDec 12, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE SURGEON NOTICED A BLACK DISCOLORATION ON THE STYLET, N ON-IMPLANTABLE PART OF THE DEVICE, TIP. ANOTHER CATHETER WAS OPENED AND THE ISSUE WAS RESOLVED. IT WAS NOTED THAT THE EVENT OCCURRED DURING A PROCEDURE, AND THAT THERE WAS NO PATIENT PRESENT. THIS WAS DISCOVERED DURING BACK TABLE SET UP AT THE BEGINNING OF THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18312104 ↗MalfunctionMar 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THERE WAS A POSSIBLE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16637273 ↗InjurySep 16, 2022Break; Fracture; Insufficient Device Problem Information; Break; Fracture; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH RIGHT CHEST SWELLING. A CT SCAN WAS PERFORMED AND SHOWED A FRACTURE IN THE SHUNT TUBING. THE SITE PROGRESSED TO SURGICAL REPAIR AND REPLACEMENT. THE DEVICE WAS NOTED TO HAVE FAILED / MALFUNCTIONED.
Patient problems: Swelling/ Edema
MAUDE report 15441815 ↗MalfunctionAug 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION REGARDING AN ARES CATHETER. IT WAS REPORTED THAT THE SITE STATED THAT THEY ARE HAVING ISSUE WITH THE CATHETER FITTING OVER THE PASSIVE CATHETER INTRODUCER (PCI) PROBE TIP. TWO SEPARATE HEALTH CARE PROFESSIONAL HAVE HAD ISSUES AT THE SITE. THE MANUFACTURER REPRESENTATIVE DIDN'T THINK THAT THE PASSIVE CATHETER INTRODUCER (PCI) TIP WAS THE ISSUE, OTHER CATHETERS FIT JUST FINE. THE CATHETER THAT WOULD NOT FIT WAS THE ARES. THE FIRST CASE THE HEALTH CARE PROFESSIONAL ABORTED NAVIGATION USE AND IMPLANTED THE ARES CATHETER INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15277485 ↗MalfunctionMar 24, 2022Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER USED DURING A SHUNT CASE. IT WAS REPORTED THAT IT WAS REPORTED THAT THERE WAS AN UNEXPECTED SLIT ON THE PERITONEAL CATHETER. NO OTHER INFORMATION, INCLUDING DELAY AND PATIENT IMPACT, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13894957 ↗InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SITE PLACE AN EXTERNAL CATHETER WHILE WAITING THE FOR THE INFECTION TO CLEAR AND THEN REPLANTED ANOTHER VENTRICULAR CATHETER.
Patient problems: Unspecified Infection
MAUDE report 12807325 ↗InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 12807211 ↗InjuryNov 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AN OFFICE VISIT ON (B)(6) 2020, THE PATIENT PRESENTED POST-OP WITH HEADACHES WORSE WHEN SITTING UP. PATIENT'S SHUNT WAS ADJUSTED FROM 1.5 TO 1.0. OFFICE VISIT ON (B)(6) 2021: PATIENT PRESENT FOR SHUNT ADJUSTMENT DUE TO CONTINUED HEADACHES. THE PATIENT'S SHUNT SETTING CONFIRMED AT 1.0 AND WAS ADJUSTED TO 0.5. OFFICE VISIT (B)(6)2021: THE PATIENT IS NOT DOING WELL WITH THE NEW SETTING AND IS HAVING EXCRUCIATING HEADACHES. OFFICE VISIT (B)(6) 2021: PATIENT PRESENTS TODAY FOR A SHUNT ADJUSTMENT S/P LPS REMOVAL AND REPLACEMENT WITH CODMAN VALVE ON (B)(6) 2021. PATIENT STATES THAT SHE IS DOING GREAT. SHE NOTES AN IMPROVEMENT IN HEADACHES. SHE STATES THAT IT STILL HURTS TO MOVE HER EYES, BUT THIS PAIN HAS SLIGHTLY IMPROVED SINCE THE REPLACEMENT WITH THE CODMAN VALVE. SHE STILL COMPLAINS OF OCCASIONAL BLURRY VISION AND STATES THAT SHE "CANNOT FOCUS ". AT SURGERY SHE WAS SE T AT 3.0, AND IS EAGER TO GO TO A LOWER SETTING OF 2.0. PATIENT HAS RESUMED TAKING LASIX 40 MG TWICE DAILY. OFFICE VISIT (B)(6) 2021: PATIENT IS A (B)(6) FEMALE WITH PAST MEDICAL HISTORY OF PSEUDOTUMOR CEREBRI PRESENTING TODAY FOR 1 MONTH FOLLOW-UP AND SHUNT ADJUSTMENT. PATIENT COMPLAINS OF WORSENING
Patient problems: Abdominal Pain; Adhesion(s); Blurred Vision; Diarrhea; Fatigue; Headache; Nausea; Vertigo; Visual Impairment
MAUDE report 12760852 ↗InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SHUNT BECAME INFECTED AND WAS REQUIRED TO BE REMOVED.
Patient problems: Unspecified Infection
MAUDE report 12077986 ↗InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SHUNT BECAME INFECTED AND WAS REQUIRED TO BE REMOVED.
Patient problems: Unspecified Infection
MAUDE report 12077836 ↗InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE CATHETER ON (B)(6) 2021 AND INITIALLY DID WELL BUT BECAME ILL IN THE POST -OPERATIVE PERIOD AND WAS READMITTED TO THE HOSPITAL AFTER IT WAS DETERMINED THAT THE PATIENT HAD AN INFECTED CATHETER. AS A RESULT, THE CATHETER WAS REMOVED ON (B)(6) 2021.
Patient problems: Unspecified Infection
MAUDE report 11971042 ↗DeathMar 15, 2021Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION IN THE BRAIN AS SEEN POST SHUNT IMPLANT PROCEDURE. IT IS UNKNOWN IF THERE WAS ANY INTERVENTION PLANNED, IF THE PRODUCT WAS DAMAGED, OR HOW THE PROCEDURE WAS COMPLETED. THE PATIENT IS NOTED TO BE DECEASED
Patient problems: Unspecified Infection
MAUDE report 11485888 ↗
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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