NA BB8C31R8Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000764968), received between Feb 29, 2024 and Oct 11, 2024 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE 1/2 X 3/8 CONNECTION ON THE ROLLER TUBING.THE AMOUNT OF BLOOD LOST BECAUSE OF THE LEAK WAS UNKNOWN.AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED BECAUSE OF THE BLOOD LOSS FROM THE LEAK. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20425537 ↗
• MalfunctionApr 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE DEVICE LEAKED BLOOD. THERE WAS 10ML OF PATIENT BLOOD LOSS. THERE WAS NO TRANSFUSION REQUIRED AS A RESULT. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THE LOCATION OF THE LEAK WAS AT THE PUMP BOOT. THE LEAK APPEARED IN ONE OTHER PACK. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018173 ↗
• MalfunctionFeb 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A LEAK. THE LEAK CAME FROM THE TUBING COMPONENT , FROM THE 3/8 X 1/2 REDUCER ON THE PUMP BOOT. THE SAME LEAK APPEARED IN MULTIPLE PACKS. THERE WAS PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK. AN UNPLANNED TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THIS LEAK. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18805524 ↗

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-1882-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, 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-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, 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-1892-2021 · Apr 29, 2021 · Terminated
  Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
• Z-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, 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-1871-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 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-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, 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-1894-2021 · Apr 29, 2021 · Terminated
  Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, 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-1889-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 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.