NA HY7J97R16Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000834432), received between Jun 14, 2023 and Aug 10, 2023 — 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 16, 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.

• MalfunctionAug 10, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF CUSTOM PACK, IT WAS REPORTED THAT THE BRIDGE IN THE PACK STARTED LEAKING DURING PRIMING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK OCCURRED WHERE THE TUBING ATTACHES TO THE CONNECTOR. IT APPEARED TO THE END USER AS IF THERE WAS NOT A GOOD SEAL BETWEEN THE TUBING AND THE CONNECTOR. THERE WAS NO VISIBLE AIR IN SYSTEM/TUBING. THE EXACT LOCATION OF THE LEAK WAS IN THE PURGE LINE IN THE CIRCUIT. THERE WAS NO DAMAGE OBSERVED TO THE DEVICE OR PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17501078 ↗
• MalfunctionJul 19, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM PACK, IT WAS REPORTED THAT THERE WAS FLUID LEAKING FROM THE SWIVEL CONNECTOR IN THE BRIDGE PORTION OF THE TUBING PACK. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. THE LEAK WAS IN THE ONLY LINE WITH SWIVEL CONNECTORS. THERE WAS NO DAMAGE TO THE DEVICE. THERE WAS NO DAMAGE TO THE PACKAGING. NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349244 ↗
• MalfunctionJun 20, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE BRIDGE IN THE CUSTOM PACK HAD A LEAK AT THE BONDED CONNECTION BY THE SWIVEL. THE LEAK WAS FOUND UPON PRIMING THE CIRCUIT (WHICH INCLUDED BANKED BLOOD). THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SAME LEAK APPEARED IN ONE OTHER PACK WITH THE SAME LOT NUMBER. THERE WAS NO COMPLETE BREAK OR PARTIAL SPLIT/BREAK IN THE TUBING. THE EXACT LOCATION OF THE LEAK IS THE BRIDGE LINE IN THE PACK. THE CUSTOMER STATED THAT NO FURTHER INFORMATION IS AVAILABLE FOR THIS OTHER OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161436 ↗
• MalfunctionJun 14, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE BRIDGE IN THE CUSTOM PACK HAD A LEAK AT THE BONDED CONNECTION BY THE SWIVEL. THE LEAK WAS FOUND UPON PRIMING THE CIRCUIT (WHICH INCLUDED BANKED BLOOD). SEE ATTACHED PHOTO. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SAME LEAK APPEARED IN ONE OTHER PACK WITH THE SAME LOT NUMBER. THERE WAS NO COMPLETE BREAK OR PARTIAL SPLIT/BREAK IN THE TUBING. THE EXACT LOCATION OF THE LEAK IS THE BRIDGE LINE IN THE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124030 ↗

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-1891-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, 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-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.
• Z-1877-2021 · Apr 29, 2021 · Terminated
  Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, 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-1879-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 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-1873-2021 · Apr 29, 2021 · Terminated
  Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, 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-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
• Z-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, 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-1881-2021 · Apr 29, 2021 · Terminated
  Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, 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.