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NA BB11J14R2Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK BB11J14R2 5PK BRIDGE · Class 2

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.

24 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. Apr 29, 2021Terminated

    Specific lots may have been manufactured with insufficient or incomplete welds.

    Z-1874-2021 · Root cause: Nonconforming Material/Component · 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-1876-2021 · Apr 29, 2021 · Terminated
    Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, 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-1872-2021 · Apr 29, 2021 · Terminated
    Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, 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-1881-2021 · Apr 29, 2021 · Terminated
    Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
  • Z-1871-2021 · Apr 29, 2021 · Terminated
    Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, 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-1880-2021 · Apr 29, 2021 · Terminated
    Medtronic HY8R62R13,Custom Pack HY8R62R13 E 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-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-1873-2021 · Apr 29, 2021 · Terminated
    Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
  • Z-1878-2021 · Apr 29, 2021 · Terminated
    Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
  • Z-1893-2021 · Apr 29, 2021 · Terminated
    Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.

…and 9 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.