NA BB8R94R9Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000629731), received between Jun 23, 2022 and Jun 23, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2022Material Separation; Air/Gas in Device; Material Separation; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED SEEING AIR BUBBLES IN THE AV LOOP LINE. THE CUSTOMER PINCHED THE TUBING NEAR THE CONNECTORS AND OBSERVED THAT THE TUBING WAS LOOSE IN THE CONNECTOR AND NOT SEALED/BONDED AS IT SHOULD HAVE BEEN. THE CUSTOMER STATED THAT THE CONNECTIONS WERE NOT TIGHT ON BOTH THE FLOW TRANSDUCER AND THE 3/8 X 3/8 LL ON ARTERIAL LINE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. IT WAS STATED THAT ALL OF THE CONNECTIONS USED TO BE TIE BANDED, BUT THEY WERE MOVED TO BONDED AT THE CUSTOMER'S REQUEST DURING THE LAST REVISION. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A SMALL BUBBLE WAS NOTED AT THE CONNECTION BETWEEN THE TUBING AND THE FLOW SENSOR. NO SUCTION OR VENTING WAS ON; THE SYSTEM WAS BEING PRIMED, AND NO BUBBLE SENSOR WAS USED. THERE WAS NO PURGE LINE, AND A BUBBLE WAS VISIBLE IN THE SYSTEM. THE CUSTOMER SQUEEZED THE CONNECTION AND FOUND IT TO BE LOOSE. THE CUSTOMER DISCONTINUED USE AND OPENED A NEW AV LOOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14785587 ↗

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-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
• Z-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, 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-1891-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, 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-1887-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, 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-1881-2021 · Apr 29, 2021 · Terminated
  Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, 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-1893-2021 · Apr 29, 2021 · Terminated
  Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, 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-1894-2021 · Apr 29, 2021 · Terminated
  Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, 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-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.

…and 10 more.