NA BB5U58R12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000274962), received between Jul 21, 2023 and Jul 21, 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.

• MalfunctionJul 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS BIO-CONSOLE EXTERNAL MOTOR DRIVE INSTRUMENT ONE OF THE LINES POPPED OFF AND SPRAYED BLOOD ALL OVER THE MOTOR. THE CUSTOMER STATED THERE WAS NOTHING WRONG WITH THE MOTOR ITSELF, THEY SIMPLY WANT THE INSIDE OF THE INSTRUMENT CLEANED. USE OF THE INSTRUMENT WAS CONTINUED WITH NO RESULTING ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION RECEIVED: THE BLOOD LOSS DUE TO THE EVENT WAS LESS THAN 100ML. A TRANSFUSION WAS REQUIRED, BUT NOT MUCH BLOOD WAS USED. THE CUSTOMER PROVIDED ADDITIONAL INFORMATION CONFIRMING THE BLOOD LOSS REPORTED WAS A RESULT OF A USER ERROR ONLY (CAUSED BECAUSE ONE OF THE SURGICAL ASSISTANTS PULLED THE VENOUS LINE OFF OF THE RESERVOIR BY MISTAKE).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17369807 ↗

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.