NA BB10R94R6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000258016), received between Mar 7, 2025 and Mar 7, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 29, 2021Terminated

   Specific lots may have been manufactured with insufficient or incomplete welds.

   Z-1873-2021 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionMar 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACK IT HAD A DAMAGED/DEFORMED PRODUCT ISSUE WHERE THE LUER CONNECTOR ON THE PIGTAIL WAS NOT ATTACHED AND CAME OFF THE TUBING. THE DEVICE WAS NOT USED, AND THERE WAS NO DAMAGE TO THE PACKAGING OR OTHER DEVICES IN THE SAME BOX. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21544680 ↗

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.