NA BB10J42R5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000171902), received between Jul 11, 2019 and Jul 11, 2019 — classified as 1 malfunction.

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

• MalfunctionJul 11, 2019Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED ONE OF THE TUBES IN THIS CUSTOM PACK SEPARATED FROM THE LUER CONNECTOR. THERE WAS APPROXIMATELY 150 ML OF BLOOD LOSS DUE TO THIS TUBING SEPARATION. NO BLOOD TRANSFUSION WAS REQUIRED. THE CUSTOMER SAID THE SEPARATION OCCURRED APPROX. 3 DAYS INTO THE SUPPORT PROCEDURE. THE SEPARATED TUBING WAS CLAMPED OUT AND REPLACED WITH A PIECE OF TUBING AND A STOPCOCK THAT THEY HAD ON THE SHELF. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8780806 ↗

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.