NA BB9Q36R3Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000554088), received between Jun 22, 2022 and Apr 24, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE ONE WAY VALVE COULD NOT PULL FLUID WHILE TESTING. THE CUSTOMER CUT IT OUT AND REPLACED IT WITH A NEW VALVE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171267 ↗
• MalfunctionApr 10, 2024Component Missing; Obstruction of Flow; Component Missing; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT WHILE HANDING UP LINES IT WAS DISCOVERED THAT THERE WAS NO TUBING ORGANIZER IN THE CLAM SHELL. THE CUSTOMER SECURED THE LINES TO THE BED AND PROCEEDED. PRIOR TO INITIATING BYPASS, WHILE CHECKING THE ONE WAY VALVES WITH FLUID, THE YELLOW (ROOT LINE) WITH THE VALVE IN IT WOULD NOT PULL FLUID. THE CUSTOMER INSPECTED THE VALVE AND CHECKED OCCLUSION AGAIN AT PUMP. THE CUSTOMER REPLACED THE ONE WAY VALVE AND THE NEW VALVE HAD NO ISSUE PULLING FLUID. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077574 ↗
• MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, LEAKY ONE WAY VALVE WAS REPORTED. PRIOR TO GOING ON BYPASS THE ONE WAY VALVE WAS TESTED AND NO LEAKING WAS NOTICED. ONCE THEY WENT ON BYPASS AND BLOOD CROSSED THE ONE WAY VALVE, THE LEAK BEGAN. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SAME LEAK DID NOT OCCUR IN MULTIPLE PACKS. LEAK ORIGINATED FROM THE ONE WAY VALVE COMPONENT. AIR AND BLOOD WAS SEEN IN THE VENT LINE, AND ABOUT 2 TO 5ML OF BLOOD WAS LOST DUE TO LEAK. NO TRANSFUSION WAS REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14998152 ↗
• MalfunctionJun 22, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE CUSTOMER OBSERVED A BROKEN CONNECTOR WHEN PRIMING THE CUSTOM TUBING PACK FOR A CASE. THE CUSTOMER STATED THAT THE CONNECTOR SPRAYED PRIME WHILE THEY WERE PRIMING THE CUSTOM TUBING PACK. THE CUSTOMER STATED THAT THERE WAS NO DAMAGE TO THE PACK AND THAT THE CONNECTOR WAS ON THE CARDIOPLEGIA SET PROXIMAL TO THE HEAT EXCHANGER. THE CUSTOMER OPENED ANOTHER CUSTOM TUBING PACK AND REPLACED THE CONNECTOR WITH A NEW ONE FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION STATING THAT THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR ANY OF THE DEVICES WITHIN THE SAME BOX/SHIPPING CONTAINER. THE CUSTOMER STATED THAT THE LEAK WAS IN THE BROKEN LUER AREA AND INTO THE SEAM WHERE IT CONNECTS TO THE BODY OF THE CONNECTOR. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONNECTOR WAS NOT COMPLETELY SEPARATED, IT WAS MORE LIKE A CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775800 ↗

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-1893-2021 · Apr 29, 2021 · Terminated
  Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, 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-1887-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, 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-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-1873-2021 · Apr 29, 2021 · Terminated
  Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
• Z-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, 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-1888-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 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-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, 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.

…and 10 more.