NA CB3Z71R23Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000876678), received between Nov 28, 2023 and Nov 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 28, 2023Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THE LINE ATTACHED TO THE OXYGENATOR CAME APART NEAR THE END OF BYPASS. THE MALE LEUR STAYED ATTACHED TO THE OXYGENATOR, HOWEVER, THE TUBING CAME OFF OF IT. THE CUSTOMER REPORTED THAT IT SHOULD NOT BE ABLE TO DETACH IN THIS LOCATION. THE LOCATION OF THE DISCONNECTION WAS FOUND ON THE CUSTOM PACK SPECIFICATION ON LINE 11 AT THE RIGHT SIDE OF THE PAGE. THE PATIENT LOST 200ML OR MORE OF BLOOD, BUT DID NOT HAVE TO GET A TRANSFUSION. THERE WAS NO PACKAGE DAMAGE NOTED, BUT THE CUSTOMER SAYS THESE CONNECTIONS ARE NOT AS SECURE AS THEY HAVE BEEN IN THE PAST. THE DEVICE WAS REPLACED, HOWEVER, WHEN THE CUSTOMER OPENED THE SECOND PACK, THE LINE WAS ALREADY DISCONNECTED INSIDE THE PACK. THE CUSTOMER HAD TO TERMINATE THE BYPASS. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT OTHER THAN THE BLOOD LOSS. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ONE LEAK FAILURE HAS OCCURRED. THE CUSTOMER REPORTED THAT THE OTHER LINES HAVE BEEN DISCARDED BECAUSE THEY DO NOT APPEAR TO BE BUILT SECURELY. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18215933 ↗

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-1888-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, 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-1877-2021 · Apr 29, 2021 · Terminated
  Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, 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-1892-2021 · Apr 29, 2021 · Terminated
  Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
• Z-1873-2021 · Apr 29, 2021 · Terminated
  Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
• Z-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
• Z-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, 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-1885-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, 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-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, 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-1880-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.

…and 10 more.