NA BB11U86R1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000648428), received between Jul 27, 2022 and Aug 15, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT WHILE DELIVERING CARDIOPLEGIA DURING CA RDIOPULMONARY BYPASS (CPB), A SPRAY OF BLOOD WAS EXITING AT THE 1/4" CONNECTOR PRIOR TO THE MYOTHERM HEAT EXCHANGER. THE CUSTOMER DID NOT WITNESS ANY ALARM CONDITIONS THAT WOULD SUGGEST AN OVER PRESSURIZATION OF THE SYSTEM. THE PUMP WAS IMMEDIATELY STOPPED AND THE BLOOD LOSS SUBSIDED. THE CUSTOMER STATED THAT THE CONNECTOR WAS CUT OUT/REMOVED FROM THE CIRCUIT AND REPLACED WITH ANOTHER 1/4" CONNECTOR FROM A DIFFERENT VENDOR AND THAT THERE WAS 10-15ML OF BLOOD LOSS AS THE RESULT OF THE EVENT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE CUSTOMER STATED THAT THE LEAK APPEARED TO BE FROM THE TUBING CONNECTION. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. A TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THE LEAK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15224592 ↗
• MalfunctionJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT UPON PRIMING THE CARDIOPULMONARY BYPASS (CPB) CIRCUIT, FLUID WAS OBSERVED LEAKING FROM THE ONE-WAY VALVE AND THE VALVE WAS REPLACED WITH A STRAIGHT CONNECT, PRIOR TO USE ON A PATIENT. THE CUSTOMER STATED THAT THE CONTAINER AND ITS CONTENTS WERE NOT DAMAGED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112606 ↗

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-1873-2021 · Apr 29, 2021 · Terminated
  Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, 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-1892-2021 · Apr 29, 2021 · Terminated
  Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, 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-1893-2021 · Apr 29, 2021 · Terminated
  Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, 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-1886-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, 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-1885-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, 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-1881-2021 · Apr 29, 2021 · Terminated
  Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, 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-1877-2021 · Apr 29, 2021 · Terminated
  Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, 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.
• Z-1890-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.

…and 10 more.