NA HY10Z49R9Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000629038), received between Aug 5, 2022 and Jun 9, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 18, 2026.

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 9, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE THE CUSTOM TUBING PACK EXPERIENCED A LEAK FROM THE CRACKED ONE-WAY VALVE COMPONENT. BLOOD LOSS OCCURRED DUE TO THE LEAK. THE LEAK WAS CONFIRMED TO ORIGINATE FROM THE ONE-WAY VALVE COMPONENT. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22167542 ↗
• MalfunctionDec 11, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THE CUSTOMER REPORTED THAT FOLLOWING THE FLUSHING OF THE CARDIOPLEGIA UP TO THE FIELD, A LEAK WAS DETECTED AT THE LUER WHEN CONNECTING THE FIELD LINE TO THE CARDIOPLEGIA LINE ON THE PUMP. THE LEAK WAS DETECTED ON THE SIDE THAT HAD THE TIE BAND. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299709 ↗
• MalfunctionDec 11, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THE CUSTOMER REPORTED THAT FOLLOWING THE FLUSHING OF THE CARDIOPLEGIA UP TO THE FIELD, A LEAK WAS DETECTED AT THE LUER WHEN CONNECTING THE FIELD LINE TO THE CARDIOPLEGIA LINE ON THE PUMP. THE LEAK WAS DETECTED ON THE SIDE THAT HAD THE TIE BAND. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299696 ↗
• MalfunctionAug 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED DURING PRIMING, A PRIMING SOLUTION WAS LEAKING OUT OF THE AV LOOP OF UNKNOWN SOURCE. THE LOOP WAS CUT OUT AND REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173673 ↗

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-1886-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
• Z-1883-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
• Z-1894-2021 · Apr 29, 2021 · Terminated
  Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, 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-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-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-1893-2021 · Apr 29, 2021 · Terminated
  Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, 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-1871-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.

…and 10 more.