NA BB8L55R8Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000991975), received between Aug 25, 2025 and Jan 12, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Increase in Pressure; Obstruction of Flow

  IT WAS REPORTED THAT DURING INITIATION OF CARDIOPULMONARY BYPASS USING THE CUSTOM TUBING PACK, A FLOW ISSUE OCCURRED IMMEDIATELY UPON INITIATION, AND HIGH ARTERIAL LINE PRESSURE WAS OBSERVED, WHICH WAS SUSPECTED TO BE RELATED TO CANNULA POSITIONING. THE ISSUE DID NOT WORSEN OVER TIME. ANTI-COAGULATION WAS ASSESSED USING THE (HMS) HEMOSTASIS MANAGEMENT SYSTEM, AND THE PRIMING SOLUTION CONSISTED OF PLASMALYTE AND HEPARIN. THE PATIENT HAD NOT PREVIOUSLY BEEN ON HEPARIN OR ANOTHER ANTI-COAGULANT THERAPY. THE PATIENT WAS GIVEN ALBUMIN, AND RE-CANNULATION WAS PERFORMED USING A LARGER CANNULA. CARDIOPULMONARY BYPASS WAS RE-INITIATED WITH SUFFICIENT FLOWS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT RE-CANNULATING USING A LARGER CANNULA WAS NOT PART OF A REGULAR PROCEDURE BUT AFTER R E-CANNULATION THE FLOW WAS NORMAL. THE CANNULA WAS MOST LIKELY THE ISSUE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO ISSUE OBSERVED WITH THE AP40 CENTRIFUGAL PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036012 ↗
• MalfunctionAug 25, 2025Gas Output Problem; Gas Output Problem

  IT WAS REPORTED THAT DURING USE OF AN AFFINITY NT OXYGENATOR THERE WERE SERIOUSLY LOW PO2S. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882198 ↗
• MalfunctionAug 25, 2025Gas Output Problem; Gas Output Problem

  IT WAS REPORTED THAT DURING USE OF AN AFFINITY NT OXYGENATOR THERE WERE SERIOUSLY LOW PO2S. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882188 ↗

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-1893-2021 · Apr 29, 2021 · Terminated
  Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, 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-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, 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-1884-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, 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-1889-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
• Z-1880-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8R62R13,Custom Pack HY8R62R13 E 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-1891-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, 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-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-1885-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, 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.

…and 10 more.