ARES™ 93092Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169762657), received between Dec 2, 2016 and Sep 17, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K110560); they may or may not involve this specific model.

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 5 most recent of 5 reports, 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 ↗
• 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 ↗
• 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 12077836 ↗
• InjuryDec 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THE PATIENT EXPERIENCED A REACTION WITH THE PERITONEAL CATHETER. THE ENTIRE SYSTEM WAS REMOVED. UPON EXPLANT, IT WAS STATED THAT THERE WAS SCARRING AND DIVERSE ADHESIONS AT THE DISTAL END OF THE PERITONEAL CATHETER THAT INSERTED INTO THE BELLY. THERE WAS NO REACTION FROM THE VALVE CONNECTION TO WHERE THE PERITONEAL CATHETER ENTERED THE BELLY. LOCULATIONS AROUND THE LIVER AND INFLAMMATORY TISSUE AROUND THE AREA WAS ALSO NOTED. REPORTEDLY, THE DOCTOR WAS GOING TO ALLERGIC TESTING AND IT MIGHT HAVE BEEN BECAUSE OF THE ANTIBIOTICS THE PATIENT WAS ALLERGIC TO.

  Patient problems: Adhesion(s); Reaction; Scarring

  MAUDE report 6142356 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110560. One submission often covers many models, so check the product and lot details in each record.

• Z-0738-2021 · Dec 8, 2020 · Open, Classified
  Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting
• Z-0739-2021 · Dec 8, 2020 · Open, Classified
  Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting o
• Z-0740-2021 · Dec 8, 2020 · Open, Classified
  Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of