NA BB10U97R11Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000956578), received between Mar 2, 2026 and Apr 21, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 reports).

25 other recalls cover devices cleared under the same FDA submission (K171979); 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.

• MalfunctionApr 21, 2026Delivered as Unsterile Product; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM PACK, IT WAS REPORTED THAT THE OUTER PACKAGING OF THE CUSTOM PACK CARDBOARD BOX WAS DAMAGED RESULTING IN A HOLE IN THE CUSTOM PACK INTERNAL TRAY , MEASURING APPROXIMATELY 3 INCHES. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24935391 ↗
• MalfunctionMar 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF CUSTOM PACKS, IT WAS REPORTED THAT THE CORNERS OF THE TRAYS WERE BROKEN OPEN. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481949 ↗
• MalfunctionMar 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF CUSTOM PACKS, IT WAS REPORTED THAT THE CORNERS OF THE TRAYS WERE BROKEN OPEN. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481942 ↗
• MalfunctionMar 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF CUSTOM PACKS, IT WAS REPORTED THAT THE CORNERS OF THE TRAYS WERE BROKEN OPEN. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481925 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171979. One submission often covers many models, so check the product and lot details in each record.

• Z-1877-2021 · Apr 29, 2021 · Terminated
  Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
• Z-1889-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
• Z-1883-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
• Z-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
• Z-1872-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
• Z-1884-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
• Z-1882-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
• Z-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1894-2021 · Apr 29, 2021 · Terminated
  Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
• Z-1886-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
• Z-1887-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
• Z-1888-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
• Z-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
• Z-1892-2021 · Apr 29, 2021 · Terminated
  Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
• Z-1879-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.

…and 10 more.