NA HY12B71R2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000941871), received between Sep 2, 2025 and Sep 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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.

• MalfunctionSep 2, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING A CARDIOPULMONARY BYPASS (CBP) PROCEDURE, THE CUSTOM TUBING PACK AND FUSION OXYGENATOR WERE ASSOCIATED WITH A FLOW ISSUE CHARACTERIZED BY LOW BLOOD FLOW, HIGH RPM, AND LOW ARTERIAL LINE PRESSURE POST OXYGENATOR BETWEEN 9:05 AM AND 9:20 AM. THE PATIENT WAS ON CPB FOR 5 MINUTES WHEN THE FLOW ISSUE OCCURRED. THE ISSUE DID NOT WORSEN OVER TIME. HEPARIN WAS USED. ACT (ACTIVATED CLOTTING TIME) VALUES WERE IN THERAPEUTIC RANGE FOR CPB THROUGHOUT THE CASE. THERE WAS 1,500ML OF ISOLYTE SOLUTION USED DURING PRIMING. AFTER THIS PERIOD OF TIME, THE BLOOD FLOWS BEGAN TO INCREASE TO MORE NORMAL VALUES. THE PERFUSION TEAM CHANGED OUT THE CENTRIFUGAL PUMP HEAD WHEN THIS FIRST OCCURRED BUT THAT DID NOT SEEM TO CHANGE THE BLOOD FLOWS. THE BLOOD FLOWS INCREASED SLOWLY OVER THIS 15 MINUTE PERIOD, UNTIL THEY WERE BACK TO NORMAL BLOOD FLOWS. THE BLOOD FLOW WAS 3.68 L/MIN WHEN CPB FIRST STARTED, AT 9:05 A.M. IT WAS DOWN TO 2.79 L/MIN, AT 9:10 A.M., 2.9 LPM AND AT 9:15 A.M. AND 4.0 LPM. AT 9:20 A.M. THE BLOOD FLOW WAS UP TO 5.39 L/MIN AND IT REMAINED BETWEEN 5.5-6.0 L/MIN FOR THE REST OF THE PROCEDURE. THE CUSTOMER INDICATED THAT THEY BELIEVED IT WAS A HIGH-PRESSURE EXCURSION E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932393 ↗

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-1886-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, 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-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
• Z-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, 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-1890-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 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-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-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, 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-1888-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, 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-1882-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.

…and 10 more.