NA 10D89R1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000115005), received between Jun 16, 2023 and Jun 16, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, A LEAKING CONNECTOR WAS NOTED. USE OF THE DEVICE WAS CONTINUED AND THERE WAS NO IMPACT TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THE AP40 KIT WAS ONLY USED FOR APPROXIMATELY 90 MINUTES AND THE AVERAGE PRESSURE WAS IN THE 290S AND NEVER EXCEEDED 320. THE LEAK ON THE KIT LOOKED LIKE IT WAS FROM AN IMPROPERLY BONDED PORTION PER THE PERFUSIONIST. NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142106 ↗

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.