NA BB7L41R23Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000412227), received between Jul 3, 2023 and Aug 18, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A LEAK IN ONE OF THE CONNECTORS (POSITIVE SIDE OF THE ROLLER HEAD 3/8 SIDE OF THE 3/8 X 1/2 CONNECTOR, LINE 12 OF THE SPEC). IT IS DISCOVERED DURING PRIMING AND AN EXTRA TIE BAND IS ADDED TO STOP THE LEAK. THE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT EFFECTS. THIS IS THE 6TH OCCURRENCE IN THE SAME LOCATION. THERE WAS NO DAMAGE TO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17570718 ↗
• MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM PACK , THE CUSTOMER REPORTED THAT THEY OBSERVED A LEAK IN ONE OF THE CONNECTORS IN THEIR CUSTOM PACK ON THE POSITIVE SIDE OF THE ROLLER HEAD 3/8 SIDE OF THE 3/8 X 1/2 CONNECTOR, LINE 12 OF THE SPEC. THE LEAK WAS OBSERVED DURING PRIMING AND AN EXTRA TIE BAND WAS ADDED TO STOP THE LEAK. THE DEVICE WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT BECAUSE OF THIS ISSUE. THE CUSTOMER STATED THERE WAS NO PACKAGE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296099 ↗
• MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION, THAT PRIOR TO USE OF A CUSTOM PACK . THE CUSTOMER REPORTED, THAT THEY OBSERVED A LEAK IN ONE OF THE CONNECTORS IN THEIR CUSTOM PACK ON THE POSITIVE SIDE OF THE ROLLER HEAD, 3/8 SIDE OF THE 3/8 X 1/2 CONNECTOR, LINE 12 OF THE SPEC. THE LEAK WAS OBSERVED, DURING PRIMING AND AN EXTRA TIE BAND WAS ADDED TO STOP THE LEAK. THE DEVICE WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT BECAUSE OF THIS ISSUE. THE CUSTOMER STATED, THERE WAS NO PACKAGE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296074 ↗
• MalfunctionJul 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258192 ↗
• MalfunctionJul 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A LEAK AT THE TUBING CONNECTOR NEXT TO ARTERIAL ROLLER HEAD TUBING. THE CUSTOMER STOPPED THE LEAK BEFORE BYPASS BY ADDING AN ADDITIONAL TIE BAND TO THE CONNECTION SITE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT REPORTED WITH THIS EVENT. THE CUSTOMER STATED THE LEAK WAS FROM LINE 12 OF TUBING SPEC ON THE 3/8 SIDE OF THE CONNECTOR ON THE POSITIVE SIDE OF THE ROLLER HEAD. THERE WAS NO DAMAGE TO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257983 ↗
• MalfunctionJul 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A LEAK AT TUBING CONNECTOR NEXT TO ARTERIAL ROLLER HEAD TUBING. THE CUSTOMER STOPPED THE LEAK BEFORE BYPASS BY ADDING AN ADDITIONAL TIE BAND TO THE CONNECTION SITE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT REPORTED WITH THIS EVENT. THE CUSTOMER STATED THE LEAK WAS FROM LINE 12 OF TUBING SPEC ON THE 3/8 SIDE OF THE CONNECTOR ON THE POSITIVE SIDE OF THE ROLLER HEAD. THERE WAS NO DAMAGE TO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246825 ↗

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-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, 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-1872-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8M63R4, Custom Pack HY8M63R4 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-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.
• Z-1873-2021 · Apr 29, 2021 · Terminated
  Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, 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-1892-2021 · Apr 29, 2021 · Terminated
  Medtronic BB8M63R5, Custom Pack BB8M63R5 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-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-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, 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-1882-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.

…and 10 more.