ARES™ 95001Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169762664), received between Jan 19, 2018 and Sep 2, 2025 — classified as 1 death, 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJan 11, 2021Migration; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD ONGOING PAIN ALONG THE RIGHT SIDE STARTING AT THE SHUNT IN THEIR HEAD DOWN UNDER THEIR BREAST INTO THEIR UPPER AND LOWER ABDOMEN AREA. THEY WERE ALSO EXPERIENCING FREQUENT URINATION. THEY WERE ON PAIN RELIEVER ALL DAY. A SHUNT STUDY X-RAY SHOWED THE SHUNT TUBING IN THE RIGHT BREAST LOOPING POSSIBLY AROUND THE LIVER.

  Patient problems: Pain

  MAUDE report 11148900 ↗
• InjurySep 30, 2020Complete Blockage; Adverse Event Without Identified Device or Use Problem; Complete Blockage; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A SHUNT ON (B)(6) 2020. THE SHUNT HAD TO BE REMOVED DUE TO OBSTRUCTION AND INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10610606 ↗
• MalfunctionJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT WAS GETTING WORSE FOR THEIR SHUNT PROCEDURE IN 2017. THEIR SYMPTOMS HAD BEEN: VOMITING, BLURRED VISION, LACK OF ENERGY, PAIN IN AREAS FROM EAR TO THEIR STOMACH, AND THEY HAD BEEN WEARING DIAPERS FROM BLADDER ISSUES. THEIR LAST SHUNT ADJUSTMENT WAS (B)(6) 2019 AFTER AN MRI.

  Patient problems: Blurred Vision; Fatigue; Incontinence; Pain; Vomiting

  MAUDE report 8729128 ↗
• MalfunctionMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD ENDOMETRIOSIS AND A FULL HYSTERECTOMY ABOUT 32 YEARS AGO. IT WAS STATED THAT THEIR STOMACH BOTHERED THEM AFTER EATING AND WHEN SITTING/GETTING UP FROM A SEATING POSITION. THE PATIENT SAW THEIR GENERAL SURGEON WHO PLACED THE DISTAL PART OF THE SHUNT ON (B)(6) 2019 FOR CONSULTATION.

  Patient problems: Abdominal Pain

  MAUDE report 8642426 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PATIENT'S MAY ADMISSION FOR CHEMOTHERAPY, THEIR SHUNT TUBING WAS VISIBLE, AND THERE WAS WOUND DEHISC ENCE. ON (B)(6) 2017, THE PATIENT'S DOCTORS ATTEMPTED TO SUTURE IT BY CLOSING THE WOUND WITH NYLON SUTURE, BACITRACIN, AND ANTIBIOTICS WERE GIVEN. DUE TO WOUND HEALING PROBLEMS AND INFECTION AS A RESULT OF THE IMMUNOCOMPROMISED STATE OF AN INFANT ON CHEMOTHERAPY, THAT PROVED UNSUCCESSFUL. ON (B)(6) 2017, THE PATIENT WAS ADMITTED TO REVISE THEIR SHUNT DUE TO FURTHER SHUNT COMPLICATIONS. THE SHUNT WAS TAPPED AT THE PATIENT'S BEDSIDE. ON (B)(6) THE DOCTOR REMOVED THEIR SHUNT, DEBRIDED THEIR SCALP TISSUE, AND PLACED AN EXTERNAL VENTRICULAR DRAIN (EVD). ON (B)(6) 2017, THE DOCTOR PLACED A NEW SHUNT AT ANOTHER LOCATION ON THE OTHER SIDE OF THE PATIENT'S HEAD.

  Patient problems: Erosion; Wound Dehiscence

  MAUDE report 8634350 ↗
• MalfunctionFeb 28, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRA-OPERATIVE DRAINAGE TEST FOUND THAT THE DRAINAGE WAS NOT SMOOTH. THE ANTIMICROBIAL CATHETERS WERE REPLACED WITH ANOTHER VENTRICULAR AND CARDIAC/PERITONEAL CATHETER WHICH THEIR FUNCTION WAS NORMAL, AND THEN ANOTHER SET OF ANTIMICROBIAL CATHETERS WHICH THEIR FUNCTION WAS ALSO NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8378780 ↗
• InjuryAug 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE CATHETER WOULD NOT ALLOW CEREBROSPINAL FLUID TO FLOW. IT WAS STATED THE PRODUCT HAD BEEN IMPLANTED AND THE DRAINAGE WAS NOT SMOOTH. THE PRODUCT WAS REPLACED AND THE PATIENT¿S STATUS WAS LISTED AS ALIVE ¿ NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7796898 ↗
• MalfunctionJun 14, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THERE WAS DIFFICULTY IMPLANTING THE VENTRICULAR CATHETER. IT WAS STATED THE CATHETER WAS NOT ABLE TO BE INSERTED INTO THE VENTRICLE OF THE PATIENT AFTER ¿MANY ATTEMPTS.¿ THE CATHETER WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7602797 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION POTENTIALLY FROM THE SHUNT. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT'S CURRENT STATUS WAS ALIVE-NO INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 7593146 ↗
• InjuryJan 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE CATHETER WAS BLOCKED AND CEREBROSPINAL FLUID COULD NOT FLOW SMOOTHLY. AN EXPLANT OF THE CATHETER WAS PLANNED FOR (B)(6) 2017. THE PATIENT'S STATUS WAS LISTED AS ALIVE - NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7206348 ↗

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-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
• 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