NA HY7W39R35Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000812126), received between Apr 3, 2023 and Sep 11, 2023 — classified as 3 malfunctions.

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

• MalfunctionSep 11, 2023Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE CUSTOMER OBSERVED A PIECE OF TUBING THAT WAS DEFORMED. IT WAS LOCATED ON THE ARTERIAL LINE PRE-FILTER. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THERE WAS NO DAMAGE TO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17717730 ↗
• MalfunctionMay 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE ONE WAY VALVE DID NOT PERFORM PROPERLY. THE CUSTOMER STATED THAT IT LEAKED AND THEY WERE NOT ABLE TO ARREST THE HEART WELL BECAUSE OF IT. THERE WAS NO DAMAGE TO THE PACKAGING OR PATIENT INJURY, BUT IT DID AFFECT THE CASE BECAUSE IT HAD TO BE CHANGED OUT AT A CRITICAL POINT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED THAT THE VENT LINE IS USED FOR THE AORTIC ROOT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE LEAK ORIGINATED FROM THE VALVE. THERE WAS VISIBLE AIR IN SYSTEM/TUBING AS IT WAS A SUCTION LINE THAT WILL ALWAYS HAVE AIR. THERE WAS MINIMAL PATIENT BLOOD LOSS. NO TRANSFUSION WAS REQUIRED AS A RESULT OF THIS LEAK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16851841 ↗
• MalfunctionApr 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16661830 ↗

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-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.
• Z-1873-2021 · Apr 29, 2021 · Terminated
  Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
• Z-1883-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
• Z-1872-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, 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-1893-2021 · Apr 29, 2021 · Terminated
  Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, 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-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-1882-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, 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-1879-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 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.

…and 10 more.