NA HY2W85R16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000515102), received between May 27, 2022 and May 27, 2022 — classified as 2 malfunctions.

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

• MalfunctionMay 27, 2022Fluid/Blood Leak; Component Missing; Fluid/Blood Leak; Component Missing

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THEY NOTICED LEAKING TUBING ON LINE 3 IN THE CUSTOM TUBING PACK. THE LEAK WAS FROM THE MVR BAG, AROUND THE SEAL WHERE THE SPIKE GOES INTO THE HOLDING BAG. THE AFFECTED TUBING WAS THE 1/2 VENOUS TUBING CONNECTION TO BAG AND 3/8 ARTERIAL TUBING TO BAG. THE CUSTOMER STATED THAT THERE WAS POTENTIAL CONTAMINATION SINCE TUBING HAD NO CAPS ON THE OPEN ENDS. THE DEVICE WAS USED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH REPORTED THAT LESS THAN 1 CC OF BLOOD LOSS OCCURRED. A TRANSFUSION WAS NOT REQUIRED BECAUSE OF THE BLOOD LOSS. NO AIR WAS NOTED IN THE SYSTEM/TUBING WHEN THE LEAK WAS OBSERVED. THE PERFUSIONIST SAID THAT THEY THOUGHT THIS ISSUE HAD HAPPENED ONE OTHER TIME, HOWEVER SPECIFIC DETAILS WERE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522187 ↗
• MalfunctionMay 27, 2022Fluid/Blood Leak; Component Missing; Fluid/Blood Leak; Component Missing

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THEY NOTICED LEAKING TUBING ON LINE 3 IN THE CUSTOM TUBING PACK. THE LEAK WAS FROM THE MVR BAG, AROUND THE SEAL WHERE THE SPIKE GOES INTO THE HOLDING BAG. THE AFFECTED TUBING WAS THE 1/2 VENOUS TUBING CONNECTION TO BAG AND 3/8 ARTERIAL TUBING TO BAG. THE CUSTOMER STATED THAT THERE WAS POTENTIAL CONTAMINATION SINCE TUBING HAD NO CAPS ON THE OPEN ENDS. THE DEVICE WAS USED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH REPORTED THAT LESS THAN 1 CC OF BLOOD LOSS OCCURRED. A TRANSFUSION WAS NOT REQUIRED BECAUSE OF THE BLOOD LOSS. NO AIR WAS NOTED IN THE SYSTEM/TUBING WHEN THE LEAK WAS OBSERVED. THE PERFUSIONIST SAID THAT THEY THOUGHT THIS ISSUE HAD HAPPENED ONE OTHER TIME, HOWEVER SPECIFIC DETAILS WERE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522141 ↗

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-1879-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 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-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-1871-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, 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-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, 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-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, 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-1888-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, 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-1884-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, 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-1890-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.

…and 10 more.