NA BB8Q36R11Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000079833), received between Jun 5, 2019 and Jun 5, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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.

• InjuryJun 5, 2019Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER 24-HOURS USE, THE CUSTOMER REPORTED SEPARATION BETWEEN THE CUSTOM TUBING PACK HUB AND THE PIG-TAIL TUBING. THE PRODUCT WAS REPLACED TO COMPLETE THE CASE. THE PATIENT LOST ABOUT 300ML OF BLOOD AND REQUIRED A BLOOD TRANSFUSION.

  Patient problems: Blood Loss

  MAUDE report 8669720 ↗

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.