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NA BB7H95R25Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK BB7H95R25 HYP MAIN · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Oct 12, 2021Open, Classified

    Product is labeled as non-pyrogenic but endotoxin testing was not performed.

    Z-0491-2022 · Root cause: Under Investigation by firm · FDA record ↗

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-1877-2021 · Apr 29, 2021 · Terminated
    Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, 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-1883-2021 · Apr 29, 2021 · Terminated
    Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
  • Z-1878-2021 · Apr 29, 2021 · Terminated
    Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, 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-1876-2021 · Apr 29, 2021 · Terminated
    Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, 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-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-1895-2021 · Apr 29, 2021 · Terminated
    Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, 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-1882-2021 · Apr 29, 2021 · Terminated
    Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, 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-1890-2021 · Apr 29, 2021 · Terminated
    Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
  • Z-1880-2021 · Apr 29, 2021 · Terminated
    Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.

…and 10 more.

Other Catheter, cannula and tubing, vascular, cardiopulmonary bypass devices

All Catheter, cannula and tubing, vascular, cardiopulmonary bypass devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.