NA BB9H23R18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000411190), received between Jun 14, 2023 and Jun 30, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THE MANIFOLD LINE WAS CRACKED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE.  PRIOR TO USE OF A SECOND CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT A CONNECTOR WAS POSSIBLY CRACKED. THE DEVICE WAS REPLACED AND THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THE ISSUES WERE NOTED IN TWO DIFFERENT PROCEDURES, ONE WITH THE MANIFOLD LINE CRACKED AND THE SECOND WAS A CONNECTOR CRACKED. THE LOCATION OF THE CRACK CANNOT BE VERIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237645 ↗
• MalfunctionJun 30, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THE MANIFOLD LINE WAS CRACKED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE.  PRIOR TO USE OF A SECOND CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT A CONNECTOR WAS POSSIBLY CRACKED. THE DEVICE WAS REPLACED AND THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THE ISSUES WERE NOTED IN TWO DIFFERENT PROCEDURES, ONE WITH THE MANIFOLD LINE CRACKED AND THE SECOND WAS A CONNECTOR CRACKED. THE LOCATION OF THE CRACK CANNOT BE VERIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237593 ↗
• MalfunctionJun 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CUSTOM TUBING PACK A LEAK WAS OBSERVED FROM ONE OF THE CONNECTORS. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. NO BLOOD LOSS OCCURRED. USE OF THE CUSTOM TUBING PACK WAS CONTINUED TO COMPLETE THE CASE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125559 ↗

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-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, 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-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-1884-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
• Z-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
• Z-1886-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
• Z-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, 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-1871-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, 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-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, 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-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.

…and 10 more.