NA BB11R03R7Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000658908), received between Aug 3, 2023 and Aug 4, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 4, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT ON TWO SEPARATE PACKS OF THE SAME LOT, A LEAK WAS SEEN AT ONE OF THE CONNECTION SITES FOR THE ARTERIAL BOOT. THIS PIECE IS ON PAGE 4, LINE 2 AND IT IS A 3/8" - 1/2" - 3/8" PIECE OF TUBING. THE LEAK OCCURRED AT THE 3/8X1/2 CONNECTOR (WITHOUT RED TAPE) ON THE 3/8" CONNECTION. THE CONNECTION SHOULD BE SOLVENT BONDED. THERE WAS A TIE BAND PRESENT BUT THE LEAK OCCURRED AND WOULD NOT STOP UNTIL A SECOND TIE BAND WAS APPLIED AND TIGHTENED BY THE CLINICIAN. THE PRODUCT WAS NOT REPLACED DURING THE PROCEDURE BUT A SECOND TIE BAND WAS ADDED TO STOP THE LEAK. THERE WAS NO ADVERSE PATIENT EFFECT. THE LEAK ORIGINATED FROM THE CONNECTION. NO AIR WAS SEEN/OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17457230 ↗
• MalfunctionAug 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM PACK, IT WAS REPORTED A LEAK WAS OBSERVED AT ONE OF THE CONNECTION SITES FOR THE ARTERIAL BOOT. THIS PIECE IS ON PAGE 4, LINE 2 AND IT IS A 3/8" - 1/2" - 3/8" PIECE OF TUBING. THE LEAK OCCURRED AT THE 3/8X1/2 CONNECTOR (WITHOUT RED TAPE) ON THE 3/8" CONNECTION. THE CUSTOMER STATED THAT THE CONNECTION SHOULD BE SOLVENT BONDED. THERE WAS A TIE BAND PRESENT BUT THE LEAK OCCURRED AND WOULD NOT STOP UNTIL A SECOND TIE BAND WAS APPLIED AND TIGHTENED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17448495 ↗

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-1881-2021 · Apr 29, 2021 · Terminated
  Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, 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-1871-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, 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-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, 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-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-1877-2021 · Apr 29, 2021 · Terminated
  Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, 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-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, 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.

…and 10 more.