NA HY9N98R6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000226664), received between Jun 14, 2023 and Jun 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

1 other recall cover devices cleared under the same FDA submission (K171308); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THE STOPCOCK LEAKED. 1-2 ML OF BLOOD WAS LOST AS A RESULT OF THE LEAK. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THERE WAS NO DAMAGE TO THE DEVICE PACKAGING. THERE WAS NO AIR NOTED IN THE SYSTEM/TUBING. NO BLOOD TRANSFUSION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125532 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171308. One submission often covers many models, so check the product and lot details in each record.

• Z-0535-2018 · Jan 3, 2018 · Terminated
  Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.