NA BB8F20R13Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000310127), received between Feb 12, 2026 and May 21, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, PRIOR TO USE, A CUSTOM TUBING PACK HAD TAPE THAT WAS NOT SECURING THE CLAMSHELL TO THE PLASTIC CASING, WHICH ALLOWED THE CLAMSHELL LID TO COME UNDONE AND RAISED CONCERN THAT THE TUBING BECAME UNSTERILE. THE TAPE WAS IDENTIFIED AS THE LOOSE/SEPARATED COMPONENT. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239444 ↗
• MalfunctionFeb 12, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THE CUSTOM TUBING PACK WAS FOUND TO HAVE TUBING CONTAINER TAPE THAT WAS NOT SECURED APPROPRIATELY. THE CUSTOMER INDICATED THAT MANY PACKS IN THE SAME LOT HAD THIS ISSUE, WITH THE TAPE APPEARING TO HAVE SHIFTED TOWARD THE FRONT BY APPROXIMATELY SIX INCHES AND THE TAPE ON ONE PACK POPPED OFF AND BECAME CONTAMINATED. THE DEVICE WAS NOT USED, AND THE AFFECTED PACK WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320744 ↗
• MalfunctionFeb 12, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THE CUSTOM TUBING PACK WAS FOUND TO HAVE TUBING CONTAINER TAPE THAT WAS NOT SECURED APPROPRIATELY. THE CUSTOMER INDICATED THAT MANY PACKS IN THE SAME LOT HAD THIS ISSUE, WITH THE TAPE APPEARING TO HAVE SHIFTED TOWARD THE FRONT BY APPROXIMATELY SIX INCHES AND THE TAPE ON ONE PACK POPPED OFF AND BECAME CONTAMINATED. THE DEVICE WAS NOT USED, AND THE AFFECTED PACK WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320739 ↗

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.