NA BB12A43R4Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000931513), received between May 3, 2024 and Nov 4, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WERE VISIBLE AIR BUBBLES TRAPPED UNDERNEATH THE Y CONNECTION. THE PURGE LINE WAS RUN OPEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598277 ↗
• MalfunctionJul 3, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT AIR WAS OBSERVED BETWEEN THE CONNECTORS AND TUBING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE SMALL POCKETS OF AIR BETWEEN THE CONNECTOR AND TUBING. NO SUCTION OR VENTING WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19663884 ↗
• MalfunctionJul 1, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS CUSTOM TUBING PACK HAD AIR OBSERVED BETWEEN THE CONNECTORS AND TUBING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642985 ↗
• MalfunctionMay 7, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS AIR/BUBBLES VISIBLE IN THE SYSTEM TUBING. THE PURGE LINE WAS RUN OPEN. THE AIR WAS TRAPPED BETWEEN THE CONNECTORS AND THE TUBING. THE BUBBLES DID NOT STOP AFTER A PERIOD OF TIME, OR AFTER AN INPUT CHANGE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258429 ↗
• MalfunctionMay 3, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS AIR/BUBBLES VISIBLE IN THE SYSTEM TUBING.THE PURGE LINE WAS RUN OPEN. THE AIR WAS TRAPPED BETWEEN THE CONNECTORS AND TUBING. THE BUBBLES DID NOT STOP AFTER A PERIOD OF TIME, OR AFTER AN INPUT CHANGE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236740 ↗
• MalfunctionMay 3, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS AIR/BUBBLES VISIBLE IN THE SYSTEM TUBING.THE PURGE LINE WAS RUN OPEN.THE AIR WAS TRAPPED BETWEEN THE CONNECTORS AND TUBING. THE BUBBLES DID NOT STOP AFTER A PERIOD OF TIME, OR AFTER AN INPUT CHANGE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236724 ↗
• MalfunctionMay 3, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS AIR/BUBBLES VISIBLE IN THE SYSTEM TUBING. THE PURGE LINE WAS RUN OPEN. THE AIR WAS TRAPPED BETWEEN THE CONNECTORS AND TUBING. THE BUBBLES DID NOT STOP AFTER A PERIOD OF TIME, OR AFTER AN INPUT CHANGE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236717 ↗
• MalfunctionMay 3, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS AIR/BUBBLES VISIBLE IN THE SYSTEM TUBING. THE PURGE LINE WAS RUN OPEN. THE AIR WAS TRAPPED BETWEEN THE CONNECTORS AND TUBING. THE BUBBLES DID NOT STOP AFTER A PERIOD OF TIME, OR AFTER AN INPUT CHANGE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236694 ↗
• MalfunctionMay 3, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS AIR/BUBBLES VISIBLE IN THE SYSTEM TUBING.THE PURGE LINE WAS RUN OPEN.THE AIR WAS TRAPPED BETWEEN THE CONNECTORS AND TUBING. THE BUBBLES DID NOT STOP AFTER A PERIOD OF TIME, OR AFTER AN INPUT CHANGE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236680 ↗

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-1881-2021 · Apr 29, 2021 · Terminated
  Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
• Z-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, 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-1884-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, 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-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
• Z-1883-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
• Z-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
• Z-1880-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, 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-1886-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
• Z-1893-2021 · Apr 29, 2021 · Terminated
  Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, 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-1882-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, 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.