NA 10R91R3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000260187), received between Jun 12, 2024 and Jun 12, 2024 — 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 12, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE CONNECTION AT THE REDUCER PRIOR TO THE 3 WAY STOPCOCK WAS LOOSE/SEPARATED. THE CUSTOM PACK HAD TO BE CHANGED OUT DUE TO ONE OF THE COMPONENTS BEING CONSIDERED A CANNULA AND IT COULD NO LONGER BE PLACED IN THE PACK. WITH THE SUBSTITUTE, THE CUSTOMER OBSERVED A LOT OF LEAKING PRIOR TO PATIENT USE. THE CUSTOMER DEEMED THAT THE SUBSTITUTE AND THIS PACK COULD NOT BE USED FOR PATIENT CARE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518067 ↗

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.