NA 42414Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169466081), received between Feb 6, 2018 and Jun 8, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K873247); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THERE WAS A VALVE FUNCTIONAL FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17085487 ↗
• InjuryMar 20, 2019Break; Fracture; Appropriate Device Problem Term/Code Not Available; Break; Fracture; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED A REPORT THAT THE CSF WOULD NOT FLOW INTO THE VALVE DUE TO IT BEING BLOCKED/DAMAGED, WHICH THE PHYSICIANS ASSUMED TO BE DUE TO A PRODUCT FAILURE. AS A RESULT THE DEVICE WAS REPLACED. NO PIECES REMAINED INSIDE THE PATIENT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8436369 ↗
• MalfunctionFeb 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHEN THE VALVE WAS CONNECTED TO THE VENTRICULAR CATHETER DURING THE PROCEDURE, THE FLOW OF CEREBROSPINAL FLUID COULD NOT BE SEEN, DESPITE MANUAL PUMPING. THE PHYSICIAN DETERMINED THAT THE VALVE DID NOT WORK AND REPLACED IT WITH ANOTHER MANUFACTURER¿S VALVE. THE PATIENT¿S STATUS WAS NOTED AS ¿OKAY/FINE.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7244770 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K873247. One submission often covers many models, so check the product and lot details in each record.

• Z-1117-2021 · Jan 11, 2021 · Open, Classified
  Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY