NA BB12E50R3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000932084), received between Aug 27, 2024 and Aug 27, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Material Separation; Component Missing; Misassembled During Installation; Material Separation; Component Missing; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS CUSTOM TUBING PACK, HAD NO ZIP TIE ON THE VENOUS SIDE OF THE PRE-BYPASS FILTER. THE CUSTOMER STATED THAT ALL PACKS IN THIS LOT NUMBER ARE MISSING THE ZIP TIE ON THE VENOUS SIDE OF THE PRE BYPASS FILTER. THE VENOUS LINE SLIPS OFF VERY EASILY. THEIR PREVIOUS PACKS ALL HAD A ZIP TIE HOLDING THE VENOUS LINE TO THE PRE-BYPASS FILTER. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE VENOUS LINE IS NOT DISCONNECTED IN THE CUSTOM PACK PRIOR TO USE. AFTER PRIMING, THE AV LOOP IS OPENED AND PASSED UP TO THE STERILE FIELD WITH BOTH THE ARTERIAL AND VENOUS LINES STILL CONNECTED TO THE PRE-BYPASS FILTER. THIS NEED TO BE DONE WITH ASEPTIC TECHNIQUE. IT IS DURING THIS MANIPULATION OF GETTING THE LINES ONTO THE STERILE FIELD THAT THE VENOUS LINE SLIPS OFF THE CONNECTOR ON THE PRE-BYPASS FILTER. THE COMPLAINT IS THAT THERE IS NO TIE BAND ON THE VENOUS SIDE OF THE PRE-BYPASS FILTER. IT SHOULD BE NOTED THAT WHEN THIS HAPPENS THE SURGICAL DRAPES BECOME SATURATED WITH THE PRIMING SOLUTION. THIS CAN LEAD TO ¿FLUID BREAKTHROUGH¿ WHICH I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20073953 ↗
• MalfunctionAug 27, 2024Material Separation; Component Missing; Misassembled During Installation; Material Separation; Component Missing; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE VENOUS SIDE OF THE PRE-BYPASS FILTER HAD NO ZIP TIE. THE CUSTOMER STATED THAT ALL PACKS IN THIS LOT NUMBER ARE MISSING THE ZIP TIE ON THE VENOUS SIDE OF THE PRE BYPASS FILTER. THE VENOUS LINE SLIPS OFF VERY EASILY. THEIR PREVIOUS PACKS ALL HAD A ZIP TIE HOLDING THE VENOUS LINE TO THE PRE-BYPASS FILTER. THE LOOSE/SEPARATED COMPONENT DID NOT FALL INTO THE PATIENT. THE DEVICE WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE VENOUS LINE IS NOT DISCONNECTED IN THE CUSTOM PACK PRIOR TO USE. AFTER PRIMING, THE AV LOOP IS OPENED AND PASSED UP TO THE STERILE FIELD WITH BOTH THE ARTERIAL AND VENOUS LINES STILL CONNECTED TO THE PRE-BYPASS FILTER. THIS NEED TO BE DONE WITH ASEPTIC TECHNIQUE. IT IS DURING THIS MANIPULATION OF GETTING THE LINES ONTO THE STERILE FIELD THAT THE VENOUS LINE SLIPS OFF THE CONNECTOR ON THE PRE-BYPASS FILTER. THE COMPLAINT IS THAT THERE IS NO TIE BAND ON THE VENOUS SIDE OF THE PRE-BYPASS FILTER. IT SHOULD BE NOTED THAT WHEN THIS HAPPENS THE SURGICAL DRAPES BECOME SATURATED WITH THE PRIMING SOLUTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20073862 ↗

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-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-1879-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1885-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 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-1887-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, 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-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-1893-2021 · Apr 29, 2021 · Terminated
  Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
• Z-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
• Z-1883-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
• Z-1888-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 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-1894-2021 · Apr 29, 2021 · Terminated
  Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.

…and 10 more.