NA HY7W39R28Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000541101), received between Jun 9, 2023 and Jun 12, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A LEAK FROM THE POSITIVE SIDE OF THE ARTERIAL ROLLER PUMP HEAD, NEAR THE CONNECTOR. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.  ADDITIONAL INFORMATION STATES THAT THE CONNECTION WAS TIE-BANDED, BUT AFTER 4 HOURS ON BYPASS WITH PRESSURE AT 300MMHG, IT STARTED TO SLOWLY DRIP. PATIENT LOST ABOUT 5ML OF BLOOD, CUSTOMER DECIDED TO CHANGE BACK TO TAPER FLEX TUBING TO PREVENT THIS FROM HAPPENING AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105384 ↗
• MalfunctionJun 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CUSTOM TUBING PACK A LEAK WAS OBSERVED ON THE POSITIVE SIDE OF THEIR ARTERIAL ROLLER PUMP HEAD WHERE THERE IS A CONNECTOR. THE CONNECTION IS TIE BANDED, BUT AFTER 4 HOURS ON BYPASS WITH PRESSURES AROUND 300MMHG IT STARTED TO SLOWLY DRIP. THE CUSTOMER STATED THAT THE PATIENT LOST A MINIMAL AMOUNT OF BLOOD, MAYBE 5ML. THE CUSTOM TUBING PACK WAS USED TO COMPLETE THE PROCEDURE. PATIENT IMPACT WAS REQUESTED BUT IT WAS REPORTED AS UNKNOWN. THE CUSTOMER HAS DECIDED TO CHANGE BACK TO TAPER FLEX TUBING TO PREVENT THIS FROM HAPPENING AGAIN. ADDITIONAL INFORMATION CONFIRMS THAT THERE WAS NO VISIBLE AIR IN THE SYSTEM/ TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098097 ↗
• MalfunctionJun 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF A CUSTOM PACK, THE CUSTOMER REPORTED A LEAK FROM THE ARTERIAL PUMP HEAD RACEWAY TUBING AT THE CONNECTOR FOR THE PUMP BOOT. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. THE EXACT LOCATION OF THE LEAK IN THE CUSTOM TUBING PACK SPECIFICATION WAS THE POSITIVE SIDE OF ARTERIAL ROLLER HEAD, SPEC LINE 8. THERE WAS NO DAMAGE TO THE PACKAGING OR THE DEVICE IDENTIFIED. THERE WAS A SMALL AMOUNT (CLINICALLY INSIGNIFICANT) OF PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK. NO TRANSFUSION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098011 ↗

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-1890-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, 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-1882-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, 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-1891-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, 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-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, 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-1880-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, 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-1877-2021 · Apr 29, 2021 · Terminated
  Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, 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-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
• Z-1894-2021 · Apr 29, 2021 · Terminated
  Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.

…and 10 more.