NA BB4S15R11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000445980), received between Mar 31, 2022 and May 4, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS A MAJOR FAILURE WITH THE PLASTIC CARDIOPLEGIA COIL IN THE PACK. THE CUSTOMER STATED THAT THEY ARE GOING TO HAVE TO CONSIDER A REVISION TO THE CUSTOM TUBING PACK. THE CUSTOMER STATED THAT THE PLASTIC CARDIOPLEGIA COIL IS SIMPLY UNACCEPTABLE, AND THE CUSTOMER HAS TRIED TO MAKE DUE WITH IT. BYPASS WAS TERMINATED TO CHANGE OUT A COIL THAT SPRAYED BLOOD ALL OVER THE ROOM. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE SURGEONS HAVE NOW DEMANDED THAT WE LOOK INTO GETTING IT OUT OF THE CUSTOM TUBING PACK AS SOON AS POSSIBLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A COMPROMISE IN THE CARDIOPLEGIA TUBING, IN THE ICE BUCKET, IMMEDIATELY PROXIMAL TO THE BEGINNING OF THE COIL ITSELF. THE COMPROMISE IN THE TUBING WAS DESCRIBED AS A "TEAR" BY ONE CLINICIAN. THE ESTIMATED BLOOD LOSS, FROM THE PATIENT, DUE TO THIS INCIDENT WAS 400ML. NO TRANSFUSION WAS REQUIRED DUE TO THIS INCIDENT. THE PRESSURIZED CARDIOPLEGIA TUBING WAS WHOLLY CONTAINED IN THE ICE BUCKET, UNDER THE LEVEL OF ICE, AT THE TIME OF

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16866967 ↗
• MalfunctionJan 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE VRV VALVE STARTED LEAKING AS SOON AS BLOOD REACHED THE VALVE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO VISIBLE AIR IN SYSTEM/TUBING. THERE WAS MINIMAL PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK. NO TRANSFUSION WAS REQUIRED. THE DEVICE WAS REPLACED AS SOON AS THE LEAK WAS NOTICED. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16174125 ↗
• MalfunctionMar 31, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THE CARDIOPLEGIA SET INCLUDED IN THE PACK HAD A DEFECT, THE BUBBLE TRAP DISTAL TO THE COOLING/HEATING COIL HAD A PRESSURE TUBING CONNECTION THAT PRESENTED WITH A SIGNIFICANT TEAR/LEAK. THIS MANIFESTED A SIGNIFICANT JET OF CARDIOPLEGIA FLUID UPON PRIMING AND PROMPTED AN EXPEDITIOUS REPLACEMENT PRIOR TO ¿PUSHING UP TO THE SURGICAL FIELD¿. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO PATIENT CARE WAS COMPROMISED. IT WAS ALSO REPORTED THAT THERE WAS NO BLOOD LOSS DUE TO THE LEAK, AND NO TRANSFUSION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13963424 ↗

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-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-1883-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
• Z-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, 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-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-1894-2021 · Apr 29, 2021 · Terminated
  Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, 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-1872-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, 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-1880-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
• Z-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, 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.

…and 10 more.