ARES™ 91101Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169762640), received between May 22, 2018 and Dec 12, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• 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 ↗
• 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 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 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD SURGERY TO REMOVE A PINEAL CYST AND DEVELOPED HYDROCEPHALUS AS A RESULT. THE PATIENT WAS IMPLANTED WITH THEIR DEVICE ON (B)(6) 2018; HOWEVER, THE PATIENT HAD A REACTION TO THE DEVICE. THE PATIENT COMPLAINED OF IRRITATION WITH THE CATHETER AND ABDOMINAL PAIN. THE DEVICE WAS EXPLANTED ON (B)(6) 2018 AND WAS REPLACED WITH ANOTHER DEVICE. THE PHYSICIAN TOOK A BIOPSY OF THE ABDOMINAL WALL AND SENT IT TO PATHOLOGY ON THE DAY OF THE EXTRACTION.

  Patient problems: Abdominal Pain; Irritation

  MAUDE report 7535363 ↗

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-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-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