NA BB12A86R2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000829568), received between Oct 15, 2025 and Oct 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (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.

• MalfunctionOct 15, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING, SPECIFICALLY THE STERILE BARRIER, OF THE CUSTOM TUBING PACKS WAS OBSERVED TO BE DAMAGED PRIOR TO USE. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291876 ↗
• MalfunctionOct 15, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING, SPECIFICALLY THE STERILE BARRIER, OF THE CUSTOM TUBING PACKS WAS OBSERVED TO BE DAMAGED PRIOR TO USE. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291703 ↗
• MalfunctionOct 15, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING, SPECIFICALLY THE STERILE BARRIER, OF THE CUSTOM TUBING PACKS WAS OBSERVED TO BE DAMAGED PRIOR TO USE. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291343 ↗
• MalfunctionOct 15, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING, SPECIFICALLY THE STERILE BARRIER, OF THE CUSTOM TUBING PACKS WAS OBSERVED TO BE DAMAGED PRIOR TO USE. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290846 ↗

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-1880-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, 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-1879-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, 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-1881-2021 · Apr 29, 2021 · Terminated
  Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, 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-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
• Z-1890-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 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-1887-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
• Z-1871-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1885-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, 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-1877-2021 · Apr 29, 2021 · Terminated
  Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
• Z-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.

…and 10 more.