NA BB10M79R8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000180713), received between Dec 12, 2019 and Dec 12, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Connection Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryDec 12, 2019Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE CUSTOM PACK THE ACCESSORY LINE CAME APART DURING THE CASE OF A PATIENT 6 DAYS ON ECMO. THE LINE WAS REPLACED TO COMPLETE THE CASE. PATIENT HAD A BLOOD LOSS OF APPROXIMATELY 50-100CC¿S. 1-UNIT OF BLOOD WAS GIVEN AFTER THE LINE FAILED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Blood Loss

  MAUDE report 9459334 ↗

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.