NA CB11H98R1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000535995), received between Oct 28, 2022 and Oct 28, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2022Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF TWO CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE VRV-100 IN THE TUBING PACKS WERE NOT ALLOWING ENOUGH BLOOD TO BE PULLED THROUGH TO ADEQUATELY VENT THE HEART. THE TUBING DISTAL TO THE VRV-100S WAS ONLY RECEIVING A TINY STREAM OF BLOOD PULLED THROUGH THE VALVES INSTEAD OF BEING FILLED WITH BLOOD. THE DUCKBILL VALVE APPEARED TO BE COLLAPSED TIGHTLY ON ITSELF. THE VALVES WERE REPLACED BY A 1/4 X 1/4 CONNECTOR WITH A SMALL NEEDLE PLACED IN THE WALL OF THE TUBING TO ALLOW EVACUATION OF AIR FROM THE CIRCUIT SHOULD THE PUMP HEAD DIRECTION GET REVERSED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT BUT IT WAS NOTED THAT EXTREME CAUTION WAS REQUIRED OF THE CCP DURING CARDIOPLEGIA ADMINISTRATION AND THE SUBSEQUENT VENTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690093 ↗
• MalfunctionOct 28, 2022Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF TWO CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE VRV-100 IN THE TUBING PACKS WERE NOT ALLOWING ENOUGH BLOOD TO BE PULLED THROUGH TO ADEQUATELY VENT THE HEART. THE TUBING DISTAL TO THE VRV-100S WAS ONLY RECEIVING A TINY STREAM OF BLOOD PULLED THROUGH THE VALVES INSTEAD OF BEING FILLED WITH BLOOD. THE DUCKBILL VALVE APPEARED TO BE COLLAPSED TIGHTLY ON ITSELF. THE VALVES WERE REPLACED BY A 1/4 X 1/4 CONNECTOR WITH A SMALL NEEDLE PLACED IN THE WALL OF THE TUBING TO ALLOW EVACUATION OF AIR FROM THE CIRCUIT SHOULD THE PUMP HEAD DIRECTION GET REVERSED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT BUT IT WAS NOTED THAT EXTREME CAUTION WAS REQUIRED OF THE CCP DURING CARDIOPLEGIA ADMINISTRATION AND THE SUBSEQUENT VENTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690091 ↗
• MalfunctionOct 28, 2022Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THREE CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE VRV-100 IN THE TUBING PACKS WERE NOT ALLOWING ENOUGH BLOOD TO BE PULLED THROUGH TO ADEQUATELY VENT THE HEART. THE TUBING DISTAL TO THE VRV-100S WAS ONLY RECEIVING A TINY STREAM OF BLOOD PULLED THROUGH THE VALVES INSTEAD OF BEING FILLED WITH BLOOD. THE DUCKBILL VALVE APPEARED TO BE COLLAPSED TIGHTLY ON ITSELF. THE VALVES WERE REPLACED BY A 1/4 X 1/4 CONNECTOR WITH A SMALL NEEDLE PLACED IN THE WALL OF THE TUBING TO ALLOW EVACUATION OF AIR FROM THE CIRCUIT SHOULD THE PUMP HEAD DIRECTION GET REVERSED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT BUT IT WAS NOTED THAT EXTREME CAUTION WAS REQUIRED OF THE CCP DURING CARDIOPLEGIA ADMINISTRATION AND THE SUBSEQUENT VENTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690070 ↗
• MalfunctionOct 28, 2022Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THREE CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE VRV-100 IN THE TUBING PACKS WERE NOT ALLOWING ENOUGH BLOOD TO BE PULLED THROUGH TO ADEQUATELY VENT THE HEART. THE TUBING DISTAL TO THE VRV-100S WAS ONLY RECEIVING A TINY STREAM OF BLOOD PULLED THROUGH THE VALVES INSTEAD OF BEING FILLED WITH BLOOD. THE DUCKBILL VALVE APPEARED TO BE COLLAPSED TIGHTLY ON ITSELF. THE VALVES WERE REPLACED BY A 1/4 X 1/4 CONNECTOR WITH A SMALL NEEDLE PLACED IN THE WALL OF THE TUBING TO ALLOW EVACUATION OF AIR FROM THE CIRCUIT SHOULD THE PUMP HEAD DIRECTION GET REVERSED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT BUT IT WAS NOTED THAT EXTREME CAUTION WAS REQUIRED OF THE CCP DURING CARDIOPLEGIA ADMINISTRATION AND THE SUBSEQUENT VENTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690052 ↗
• MalfunctionOct 28, 2022Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THREE CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE VRV-100 IN THE TUBING PACKS WERE NOT ALLOWING ENOUGH BLOOD TO BE PULLED THROUGH TO ADEQUATELY VENT THE HEART. THE TUBING DISTAL TO THE VRV-100S WAS ONLY RECEIVING A TINY STREAM OF BLOOD PULLED THROUGH THE VALVES INSTEAD OF BEING FILLED WITH BLOOD. THE DUCKBILL VALVE APPEARED TO BE COLLAPSED TIGHTLY ON ITSELF. THE VALVES WERE REPLACED BY A 1/4 X 1/4 CONNECTOR WITH A SMALL NEEDLE PLACED IN THE WALL OF THE TUBING TO ALLOW EVACUATION OF AIR FROM THE CIRCUIT SHOULD THE PUMP HEAD DIRECTION GET REVERSED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT BUT IT WAS NOTED THAT EXTREME CAUTION WAS REQUIRED OF THE CCP DURING CARDIOPLEGIA ADMINISTRATION AND THE SUBSEQUENT VENTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690048 ↗

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-1879-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, 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-1893-2021 · Apr 29, 2021 · Terminated
  Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, 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-1891-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, 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-1885-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, 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-1883-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
• Z-1877-2021 · Apr 29, 2021 · Terminated
  Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, 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-1882-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, 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-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.

…and 10 more.