NA HY2U43R17Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000344467), received between May 10, 2022 and Jun 15, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.

Recalls naming this device

1. Dec 12, 2022Class IIOpen, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED BLOOD SPURTING FROM THE CUSTOM PACK'S ONE-WAY-VALVE. THE VALVE WAS REPLACED. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION FROM THE CUSTOMER: AFTER UNEVENTFUL INITIATION OF BYPASS AND WHEN TESTING THE FUNCTION OF THE LEFT VENTRICULAR VENT LINE OF THE TUBING PACK (IDENTIFIED AS LINE 8 ON PAGE 7 OF 10 OF DRAWING FOR HY2U43R17) BLOOD WAS SPURTING FROM THE ONE WAY VALVE. THE ROLLER PUMP USED FOR THE VENT LINE WAS STOPPED, THE VENT LINE WAS CLAMPED DISTAL AND PROXIMAL TO THE ONE-WAY VALVE, THE COMPONENT WAS CUT OUT AND WAS REPLACED WITH A SUBSTITUTE ONE-WAY VALVE. FOR AN UNSPECIFIED REASON THE SURGEON WAS UNABLE TO INSERT A RETROGRADE CARDIOPLEGIA CANNULA AND ONLY ANTEGRADE CARDIOPLEGIA WAS GIVEN DURING THE CABG X 2 PROCEDURE. ADDITIONAL INFO FROM THE SALES REP: THERE IS NO ALLEGATION AGAINST THE RETROGRADE CANNULA.  THE IDENTIFIED CULPRIT DEVICE IS THE VRV IN THE LEFT VENT LINE. SINCE BLOOD WAS SPURTING FROM THE POTENTIALLY LEAKY SITE THERE IS LITTLE INFO ON AN ESTIMATED BLOOD LOSS. BLOOD WAS A MESS TO CLEAN UP SO LIKELY 30-50 CC¿S NO TRANSFUSION ADMINISTERED AND NO UNTOWARD EFFECT ON THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134280 ↗
• MalfunctionJul 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT DURING PRIMING, THEY OBSERVED SOLUTION DRIPPING FROM THE CONNECTION POINT OF THE BLOOD OUTLET LINE AND THE MYOTHERM. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONNECTION SITE WAS NOT LOOSE AND THE ACCOUNT REPORTED THAT THE LEAK DID NOT SEEM TO BE FROM UNDER THE TIE-BANDED CONNECTION, BUT PERHAPS A SMALL CRACK JUST ABOVE THE CONNECTION SITE. THERE WAS NO AIR SEEN ANYWHERE IN THE CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025942 ↗
• MalfunctionJul 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT DURING PRIMING, THEY OBSERVED SOLUTION DRIPPING FROM THE CONNECTION POINT OF THE BLOOD OUTLET LINE AND THE MYOTHERM. THE DEVICE WAS REPLACED WITH A DEVICE FROM THE SAME LOT AND THIS TOO LEAKED AT THE SAME POINT. A THIRD DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONNECTION SITE WAS NOT LOOSE AND THE ACCOUNT REPORTED THAT THE LEAK DID NOT SEEM TO BE FROM UNDER THE TIE-BANDED CONNECTION, BUT PERHAPS A SMALL CRACK JUST ABOVE THE CONNECTION SITE. THERE WAS NO AIR SEEN ANYWHERE IN THE CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025941 ↗
• MalfunctionMay 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT DURING SETUP THEY NOTICED PRIMING SOLUTION DRIPPING FROM THE MYOTHERM CARDIOPLEGIA DEVICE. THE CUSTOMER STATED THAT THE LEAK APPEARED TO BE AT THE TIE-BAND LOCATION. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347514 ↗

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-1872-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, 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-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, 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-1873-2021 · Apr 29, 2021 · Terminated
  Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, 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-1883-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
• Z-1893-2021 · Apr 29, 2021 · Terminated
  Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, 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-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
• Z-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, 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-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.

…and 10 more.