NA BB10V62RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000233372), received between Dec 15, 2025 and Feb 24, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE OUTER PACKAGING FOR THESE CUSTOM TUBING PACKS WERE DAMAGED PRIOR TO USE. DEVICES IN THE SAME BOX/SHIPPING CONTAINERS WERE NOT DAMAGED. THE CUSTOM TUBING PACKS WERE NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION VIA ANALYSIS OF THE RETURNED DEVICES THAT THERE WAS ALSO DAMAGE TO THE STERILE BARRIER IN ALL OF THE CUSTOM TUBING PACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428367 ↗
• MalfunctionFeb 24, 2026Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE OUTER PACKAGING FOR THESE CUSTOM TUBING PACKS WERE DAMAGED PRIOR TO USE. DEVICES IN THE SAME BOX/SHIPPING CONTAINERS WERE NOT DAMAGED. THE CUSTOM TUBING PACKS WERE NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION VIA ANALYSIS OF THE RETURNED DEVICES THAT THERE WAS ALSO DAMAGE TO THE STERILE BARRIER IN ALL OF THE CUSTOM TUBING PACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428341 ↗
• MalfunctionFeb 24, 2026Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE OUTER PACKAGING FOR THESE CUSTOM TUBING PACKS WERE DAMAGED PRIOR TO USE. DEVICES IN THE SAME BOX/SHIPPING CONTAINERS WERE NOT DAMAGED. THE CUSTOM TUBING PACKS WERE NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION VIA ANALYSIS OF THE RETURNED DEVICES THAT THERE WAS ALSO DAMAGE TO THE STERILE BARRIER IN ALL OF THE CUSTOM TUBING PACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428242 ↗
• MalfunctionDec 15, 2025Delivered as Unsterile Product; Material Separation; Misassembled During Installation; Delivered as Unsterile Product; Material Separation; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS NO TAPE ON THE AV LOOP, CAUSING THE TOP COVER TO FALL OFF DURING SET UP, AND MAKING THE DEVICE NON STERILE AND HENCE UNUSABLE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804664 ↗

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.