NA BB10S02R6Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000299002), received between Aug 10, 2022 and Mar 25, 2025 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE A CUSTOM TUBING PACK HAD A LOOSE/SEPARATED COMPONENT AT THE PIGTAIL CONNECTION AT THE LUER. THE LO OSE/SEPARATED COMPONENT DID NOT FALL INTO THE PATIENT. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686124 ↗
• MalfunctionAug 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT DURING SET UP AND PRIMING, A LARGE PUDDLE OF CRYSTALLOID WAS FOUND BENEATH THE CIRCUIT ON THE FLOOR THE NEXT DAY. THE LEAK WAS TRACED TO THE PRE-BYPASS FILTER. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION STATING THAT THE LEAK ORIGINATED FROM THE COMPONENT AND THERE WAS A SMALL DRIP COMING OUT OF THE SEAM AT THE TOP OF THE FILTER. THERE WERE NO VISIBLE AIR IN THE SYSTEM/TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201735 ↗

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.