NA HY10U10R4Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000542139), received between Mar 8, 2022 and Mar 21, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 12, 2022Open, Classified

   An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

   Z-1027-2023 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THE ARTERIAL INLET ON THE FUSION OXYGENATOR WAS BROKEN. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE PATIENT EFFECTS OCCURRED. ADDITIONAL INFORMATION CONFIRMED THAT THERE IS NO DAMAGE TO THE PACKAGE, THE DEVICE OR THE COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838620 ↗
• MalfunctionMar 16, 2022Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THE ARTERIAL INLET PORT HAD BROKEN OFF OF THE FUSION OXYGENATOR. THE CUSTOM TUBING PACK WAS REPLACED WITH A NEW PACK TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE PATIENT EFFECTS OCCURRED. ADDITIONAL INFORMATION: THERE WAS NO NOTICEABLE DAMAGE TO SHIPPING CONTAINERS OR TO THE PACKAGING. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13788649 ↗
• MalfunctionMar 9, 2022Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE CUSTOM TUBING PACKS, THE CUSTOMER REPORTED THAT THE BLOOD INLET CONNECTION SITE HAS BEEN BROKEN OFF OF THREE FUSION OXYGENATORS. SEE THE ATTACHED IMAGES. THE CUSTOM TUBING PACKS WERE REPLACED WITH NEW PACKS CASES. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE PATIENT EFFECTS OCCURRED. ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THEY BELIEVE THAT THE PACKAGING DESIGN IS THE ISSUE. THERE WAS NO NOTICEABLE DAMAGE TO SHIPPING CONTAINERS OR TO THE PACKAGING. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13706392 ↗
• MalfunctionMar 9, 2022Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE CUSTOM TUBING PACKS, THE CUSTOMER REPORTED THAT THE BLOOD INLET CONNECTION SITE HAS BEEN BROKEN OFF OF THREE FUSION OXYGENATORS. THE CUSTOM TUBING PACKS WERE REPLACED WITH NEW PACKS CASES. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE PATIENT EFFECTS OCCURRED. ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THEY BELIEVE THAT THE PACKAGING DESIGN IS THE ISSUE. THERE WAS NO NOTICEABLE DAMAGE TO SHIPPING CONTAINERS OR TO THE PACKAGING. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13706127 ↗
• MalfunctionMar 8, 2022Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THE BLOOD INLET CONNECTION SITE HAS BEEN BROKEN OFF, OF THE FUSION OXYGENATOR. THE CUSTOM TUBING PACK WAS REPLACED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE PATIENT EFFECTS OCCURRED. ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THEY BELIEVE THAT THE PACKAGING DESIGN IS THE ISSUE. THERE WAS NO NOTICEABLE DAMAGE TO SHIPPING CONTAINERS OR TO THE PACKAGING. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694141 ↗

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-1885-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 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-1877-2021 · Apr 29, 2021 · Terminated
  Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, 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-1892-2021 · Apr 29, 2021 · Terminated
  Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
• Z-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, 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-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 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-1882-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, 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-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-1872-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
• Z-1881-2021 · Apr 29, 2021 · Terminated
  Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.

…and 10 more.