NA BB10B28R5Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000179991), received between May 12, 2025 and Mar 10, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Delivered as Unsterile Product; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE PACKAGING WAS RIPPED, CAUSING DAMAGE TO THE STERILE BARRIER. NO OTHER DEVICES IN THE SAME SHIPPING CONTAINER WERE DAMAGED. SEE ATTACHED PHOTO. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561123 ↗
• MalfunctionFeb 16, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THE CUSTOM TUBING PACK WAS FOUND WITH DAMAGED OUTER PACKAGING AND AN AFFINITY CENTRIFUGAL PUMP CONE WAS ALSO DAMAGED. THE DEVICE WAS NOT USED AND WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344512 ↗
• MalfunctionJan 16, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THE CUSTOM TUBING PACK WAS FOUND WITH A PUNCTURED TOP PEEL LID, DAMAGE TO THE INNER PACKAGING, AND DAMAGE TO THE STERILE BARRIER PRIOR TO USE. THE DEVICE WAS NOT USED, AND NO OTHER DEVICES IN THE SAME BOX OR SHIPPING CONTAINER WERE DAMAGED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092098 ↗
• MalfunctionNov 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE CUSTOM TUBING PACK WAS OBSERVED TO HAVE A RIP IN THE PEEL POUCH PRIOR TO USE. THERE WAS NO DAMAGE TO THE OTHERS PACKAGING OR TO OTHER DEVICES IN THE SAME BOX OR SHIPPING CONTAINER. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654334 ↗
• MalfunctionMay 12, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO USE OF A CUSTOM TUBING PACK THERE WAS A LEAK OBSERVED FROM THE TUBING COMPONENT AND A CUT WAS IDENTIFIED IN THE TUBING. THE LEAK WAS LOCATED ON THE ARTERIAL LINE. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002129 ↗

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.