NA BB2493R47Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000648602), received between Dec 12, 2025 and Jan 23, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (11 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Dec 12, 2022Open, Classified

   An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

   Z-1027-2023 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOM TUBING PACK WAS OBSERVED TO HAVE A HOLE ABOVE THE STERILE LINE, RAISING CONCERNS ABOUT STERILITY PRIOR TO USE. THE SIZE OF THE HOLE WAS DESCRIBED AS NOT LARGE, AND IT WAS CONFIRMED THAT A COMPLETE BREAK DID NOT OCCUR. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159976 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE TWO CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE FOAM IN BOTH PACKS WAS MISPLACED. THE FOAM PIECES IN THE TABLE TRAY WERE LOOSE BUT DID NOT FALL INTO PATIENT. THE DEVICES WERE REPLACED. THE ISSUE WAS OBSERVED DURING SET UP; THE TUBING PACKS WERE NOT USED DUE TO STERILITY CONCERNS. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS A FOAM PIECE THAT WAS DISPLACED AND THAT COMPROMISED STERILITY OF THE CLAMSHELL. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER REITERATED THAT THE CLAMSHELL LINES AND TUBING SEEM TO BE WRAPPED UP PRETTY TIGHTLY AND IF THERE IS ANY STRESS PUT ON THE LINES, IT MAY CAUSE THE SHIFTING AND MAY RESULT IN THE FOAM MOVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129126 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE TWO CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE FOAM IN BOTH PACKS WAS MISPLACED. THE FOAM PIECES IN THE TABLE TRAY WERE LOOSE, BUT DID NOT FALL INTO PATIENT. THE DEVICES WERE REPLACED. THE ISSUE WAS OBSERVED DURING SET UP, THE TUBING PACKS WERE NOT USED DUE TO STERILITY CONCERNS. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS A FOAM PIECE THAT WAS DISPLACED AND THAT COMPROMISED STERILITY OF THE CLAMSHELL. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER REITERATED THAT THE CLAMSHELL LINES AND TUBING SEEM TO BE WRAPPED UP PRETTY TIGHTLY AND IF THERE IS ANY STRESS PUT ON THE LINES, IT MAY CAUSE THE SHIFTING AND MAY RESULT IN THE FOAM MOVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129060 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT THESE CUSTOM TUBING PACKS HAD A MISSING FOAM PIECE PUSHED INTO THE STERILE CLAM SHELL, COMPROMISING STERILITY PRIOR TO USE. ADDITIONALLY, THERE WERE LOOSE/SEPARATED FOAM PIECES FOUND IN THE TABLE TRAY LOCATED ON PAGE 4 OF THE CUSTOM PACK SPECIFICATION. THE HEALTHCARE PROFESSIONAL NOTED THAT THE MISSING FOAM PIECE EXPOSED THE STERILE INSIDE OF THE CLAMSHELL TO THE OUTSIDE, AND THE ONLY WAY TO RETRIEVE IT WOULD BE TO OPEN THE CLAMSHELL. THE CUSTOMER EXPRESSED FRUSTRATION AS THIS ISSUE HAD RECURRED AND QUESTIONED IF THE SETUP OR STERILIZATION PROCESS MIGHT BE CONTRIBUTING TO THE FOAM'S MOVEMENT. THEY QUERIED WHETHER THERE WOULD BE A METHOD TO REWORK THE CLAM SHELL INCLUDING THE TIGHTNESS OF THE COIL IN THE CLAM SHELL DURING SET UP WHICH THEY STATED MAY BE ATTRIBUTING TO THE FOAM MOVING DURING SOME POINT IN SETUP OR STERILIZATION. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128993 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT THESE CUSTOM TUBING PACKS HAD A MISSING FOAM PIECE PUSHED INTO THE STERILE CLAM SHELL, COMPROMISING STERILITY PRIOR TO USE. ADDITIONALLY, THERE WERE LOOSE/SEPARATED FOAM PIECES FOUND IN THE TABLE TRAY LOCATED ON PAGE 4 OF THE CUSTOM PACK SPECIFICATION. THE HEALTHCARE PROFESSIONAL NOTED THAT THE MISSING FOAM PIECE EXPOSED THE STERILE INSIDE OF THE CLAMSHELL TO THE OUTSIDE, AND THE ONLY WAY TO RETRIEVE IT WOULD BE TO OPEN THE CLAMSHELL. THE CUSTOMER EXPRESSED FRUSTRATION AS THIS ISSUE HAD RECURRED AND QUESTIONED IF THE SETUP OR STERILIZATION PROCESS MIGHT BE CONTRIBUTING TO THE FOAM'S MOVEMENT. THEY QUERIED WHETHER THERE WOULD BE A METHOD TO REWORK THE CLAM SHELL INCLUDING THE TIGHTNESS OF THE COIL IN THE CLAM SHELL DURING SET UP WHICH THEY STATED MAY BE ATTRIBUTING TO THE FOAM MOVING DURING SOME POINT IN SETUP OR STERILIZATION. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128930 ↗
• MalfunctionDec 17, 2025Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE FOAM WAS PUSHED IN AND SHIFTED ON THE CLAMSHELL, MAKING THE LINES UNSTERILE. THERE WAS NO DAMAGE TO THE PACKAGING AND OTHER DEVICES IN THE SAME BOX WERE NOT DAMAGED. THE CUSTOMER OPENED A NEW CUSTOM PACK TO REPLACE AND SWAP OUT THE CLAMSHELL PART ONLY, AS THE REST OF THE PACK WAS NOT AFFECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830824 ↗
• MalfunctionDec 15, 2025Delivered as Unsterile Product; Material Separation; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Material Separation; Manufacturing, Packaging or Shipping Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME THIS CUSTOM TUBING PACK, IT WAS REPORTED THAT THE FOAM WAS MISPLACED. THE FOAM PIECES IN THE TABLE TRAY WERE LOOSE. THE USE OF THE PACK WAS UNSPECIFIED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23806505 ↗
• MalfunctionDec 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A CUSTOM TUBING PACK WAS OBSERVED TO HAVE A MISSING FOAM PIECE IN THE STERILE CLAM SHELL PRIOR TO USE, COMPROMISING STERILITY. THE HEALTHCARE PROFESSIONAL NOTED THAT THE MISSING FOAM PIECE APPEARED TO BE PUSHED INTO THE STERILE CLAM SHELL, EXPOSING THE STERILE INSIDE TO THE OUTSIDE ENVIRONMENT. THE ONLY WAY TO RETRIEVE THE PIECE WOULD BE TO OPEN THE CLAMSHELL. THE ISSUE WAS LOCATED ON PAGE 4 OF THE CUSTOM PACK SPECIFICATION. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804823 ↗
• MalfunctionDec 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO USE, THE CUSTOM TUBING PACK WAS FOUND WITH A DAMAGED CLAMSHELL, WHERE BOTH THE PLASTIC AND TAPE WERE CRACKED, AND THE STERILE PAPER TAPE WAS STICKING OUT OF THE CLAMSHELL. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804729 ↗
• MalfunctionDec 12, 2025Delivered as Unsterile Product; Misassembled During Installation; Delivered as Unsterile Product; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE FOAM THAT HOLDS THE TUBING IN THE CLAM SHELL WAS PUSHED IN/SLID TO THE SIDE, THEREFORE, THERE WAS NO BARRIER BETWEEN THE STERILE AND UNSTERILE. THE LOCATION OF THE ISSUE WAS ON LINE 1, PAGE 8 OF THE CUSTOM PACK SPECIFICATION. THERE WAS NO DAMAGE NOTICED TO THE OUTER BOX OR THE PLASTIC TRAY HOUSING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STERILE SEAL TO THE PLASTIC TRAY HOUSING WAS SEALED. THE FOAM ON BOTTOM OF THE CLAM SHELL WAS MOVED OVER AND EXPOSED TO OPEN AIR AND THERE WAS NO STERILE SEAL FROM THE BOTTOM ON THE CLAM SHELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789422 ↗
• MalfunctionDec 12, 2025Delivered as Unsterile Product; Misassembled During Installation; Delivered as Unsterile Product; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE FOAM THAT HOLDS THE TUBING IN THE CLAM SHELL WAS PUSHED IN/SLID TO THE SIDE, THEREFORE, THERE WAS NO BARRIER BETWEEN THE STERILE AND UNSTERILE. THE LOCATION OF THE ISSUE WAS ON LINE 1, PAGE 8 OF THE CUSTOM PACK SPECIFICATION. THERE WAS NO DAMAGE NOTICED TO THE OUTER BOX OR THE PLASTIC TRAY HOUSING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STERILE SEAL TO THE PLASTIC TRAY HOUSING WAS SEALED. THE FOAM ON BOTTOM OF THE CLAM SHELL WAS MOVED OVER AND EXPOSED TO OPEN AIR AND THERE WAS NO STERILE SEAL FROM THE BOTTOM ON THE CLAM SHELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789402 ↗

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-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-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, 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-1871-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 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-1879-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, 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-1880-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, 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-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1883-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
• Z-1891-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, 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-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.

…and 10 more.