Affinity Fusion® BB841 (UDI 00643169354869)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00643169354869), received between Mar 25, 2022 and Jul 8, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (18 reports).

2 FDA recall records name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K132972, K203111); 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. 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-1024-2023 · Root cause: Process change control · FDA record ↗

2. Nov 16, 2016Terminated

   Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.

   Z-0826-2017 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR IT WAS REPORTED BLOOD LEAKED, AND SEVERAL PRODUCTS LEAKED BLOOD CONTINUOUSLY. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE DEVICE, THE PACKAGING OR OTHER CONTENTS WITHIN THE PACKAGE (EX. DEVICES IN A TRAY OR CUSTOM PACK). THE EXACT NUMBER OF DEVICES WHICH LEAKED WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25749836 ↗
• MalfunctionJul 8, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR IT WAS REPORTED BLOOD LEAKED, AND SEVERAL PRODUCTS LEAKED BLOOD CONTINUOUSLY. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE DEVICE, THE PACKAGING OR OTHER CONTENTS WITHIN THE PACKAGE (EX. DEVICES IN A TRAY OR CUSTOM PACK). THE EXACT NUMBER OF DEVICES WHICH LEAKED WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25749831 ↗
• MalfunctionFeb 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS (CVRS) IT WAS REPORTED THAT WHEN THE AGENT RECEIVED THE PRODUCT FOR INSPECTION IN THE WAREHOUSE, IT WAS FOUND THAT THE OUTER PACKAGING OF NINE DEVICES WERE DAMAGED, AND THE ASEPTIC PACKAGING OF THE DEVICE INSIDE WAS FOUND TO BE SQUEEZED AND PARTIALLY CRACKED. THE PRODUCTS COULD NOT BE SENT TO THE HOSPITAL AS THE HOSPITAL REFUSED TO ACCEPT THEM. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WEREN'T ANY MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. THE STERILE SEAL WAS INTACT. HOWEVER, THERE WAS SEVERE SQUEEZE MARK. THE DEVICES WERE LOCATED IN THE SEAL. THE SALES REP CONFIRMED THAT ALL THE DAMAGED PACKAGING BELONGED TO THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241542 ↗
• MalfunctionFeb 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS (CVRS) IT WAS REPORTED THAT WHEN THE AGENT RECEIVED THE PRODUCT FOR INSPECTION IN THE WAREHOUSE, IT WAS FOUND THAT THE OUTER PACKAGING OF NINE DEVICES WERE DAMAGED, AND THE ASEPTIC PACKAGING OF THE DEVICE INSIDE WAS FOUND TO BE SQUEEZED AND PARTIALLY CRACKED. THE PRODUCTS COULD NOT BE SENT TO THE HOSPITAL AS THE HOSPITAL REFUSED TO ACCEPT THEM. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WEREN'T ANY MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. THE STERILE SEAL WAS INTACT. HOWEVER, THERE WAS SEVERE SQUEEZE MARK. THE DEVICES WERE LOCATED IN THE SEAL. THE SALES REP CONFIRMED THAT ALL THE DAMAGED PACKAGING BELONGED TO THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241492 ↗
• MalfunctionFeb 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS (CVRS) IT WAS REPORTED THAT WHEN THE AGENT RECEIVED THE PRODUCT FOR INSPECTION IN THE WAREHOUSE, IT WAS FOUND THAT THE OUTER PACKAGING OF NINE DEVICES WERE DAMAGED, AND THE ASEPTIC PACKAGING OF THE DEVICE INSIDE WAS FOUND TO BE SQUEEZED AND PARTIALLY CRACKED. THE PRODUCTS COULD NOT BE SENT TO THE HOSPITAL AS THE HOSPITAL REFUSED TO ACCEPT THEM. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WEREN'T ANY MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. THE STERILE SEAL WAS INTACT. HOWEVER, THERE WAS SEVERE SQUEEZE MARK. THE DEVICES WERE LOCATED IN THE SEAL. THE SALES REP CONFIRMED THAT ALL THE DAMAGED PACKAGING BELONGED TO THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241469 ↗
• MalfunctionFeb 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS (CVRS) IT WAS REPORTED THAT WHEN THE AGENT RECEIVED THE PRODUCT FOR INSPECTION IN THE WAREHOUSE, IT WAS FOUND THAT THE OUTER PACKAGING OF NINE DEVICES WERE DAMAGED, AND THE ASEPTIC PACKAGING OF THE DEVICE INSIDE WAS FOUND TO BE SQUEEZED AND PARTIALLY CRACKED. THE PRODUCTS COULD NOT BE SENT TO THE HOSPITAL AS THE HOSPITAL REFUSED TO ACCEPT THEM. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WEREN'T ANY MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. THE STERILE SEAL WAS INTACT. HOWEVER, THERE WAS SEVERE SQUEEZE MARK. THE DEVICES WERE LOCATED IN THE SEAL. THE SALES REP CONFIRMED THAT ALL THE DAMAGED PACKAGING BELONGED TO THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241343 ↗
• MalfunctionFeb 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS (CVRS) IT WAS REPORTED THAT WHEN THE AGENT RECEIVED THE PRODUCT FOR INSPECTION IN THE WAREHOUSE, IT WAS FOUND THAT THE OUTER PACKAGING OF NINE DEVICES WERE DAMAGED, AND THE ASEPTIC PACKAGING OF THE DEVICE INSIDE WAS FOUND TO BE SQUEEZED AND PARTIALLY CRACKED. THE PRODUCTS COULD NOT BE SENT TO THE HOSPITAL AS THE HOSPITAL REFUSED TO ACCEPT THEM. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WEREN'T ANY MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. THE STERILE SEAL WAS INTACT. HOWEVER, THERE WAS SEVERE SQUEEZE MARK. THE DEVICES WERE LOCATED IN THE SEAL. THE SALES REP CONFIRMED THAT ALL THE DAMAGED PACKAGING BELONGED TO THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241324 ↗
• MalfunctionFeb 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS (CVRS) IT WAS REPORTED THAT WHEN THE AGENT RECEIVED THE PRODUCT FOR INSPECTION IN THE WAREHOUSE, IT WAS FOUND THAT THE OUTER PACKAGING OF NINE DEVICES WERE DAMAGED, AND THE ASEPTIC PACKAGING OF THE DEVICE INSIDE WAS FOUND TO BE SQUEEZED AND PARTIALLY CRACKED. THE PRODUCTS COULD NOT BE SENT TO THE HOSPITAL AS THE HOSPITAL REFUSED TO ACCEPT THEM. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WEREN'T ANY MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. THE STERILE SEAL WAS INTACT. HOWEVER, THERE WAS SEVERE SQUEEZE MARK. THE DEVICES WERE LOCATED IN THE SEAL. THE SALES REP CONFIRMED THAT ALL THE DAMAGED PACKAGING BELONGED TO THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241194 ↗
• MalfunctionFeb 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS (CVRS) IT WAS REPORTED THAT WHEN THE AGENT RECEIVED THE PRODUCT FOR INSPECTION IN THE WAREHOUSE, IT WAS FOUND THAT THE OUTER PACKAGING OF NINE DEVICES WERE DAMAGED, AND THE ASEPTIC PACKAGING OF THE DEVICE INSIDE WAS FOUND TO BE SQUEEZED AND PARTIALLY CRACKED. THE PRODUCTS COULD NOT BE SENT TO THE HOSPITAL AS THE HOSPITAL REFUSED TO ACCEPT THEM. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WEREN'T ANY MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. THE STERILE SEAL WAS INTACT. HOWEVER, THERE WAS SEVERE SQUEEZE MARK. THE DEVICES WERE LOCATED IN THE SEAL. THE SALES REP CONFIRMED THAT ALL THE DAMAGED PACKAGING BELONGED TO THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241121 ↗
• MalfunctionFeb 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS (CVRS) IT WAS REPORTED THAT WHEN THE AGENT RECEIVED THE PRODUCT FOR INSPECTION IN THE WAREHOUSE, IT WAS FOUND THAT THE OUTER PACKAGING OF NINE DEVICES WERE DAMAGED, AND THE ASEPTIC PACKAGING OF THE DEVICE INSIDE WAS FOUND TO BE SQUEEZED AND PARTIALLY CRACKED. THE PRODUCTS COULD NOT BE SENT TO THE HOSPITAL AS THE HOSPITAL REFUSED TO ACCEPT THEM. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECTOCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WEREN'T ANY MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. THE STERILE SEAL WAS INTACT. HOWEVER, THERE WAS SEVERE SQUEEZE MARK. THE DEVICES WERE LOCATED IN THE SEAL. THE SALES REP CONFIRMED THAT ALL THE DAMAGED PACKAGING BELONGED TO THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241099 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED AFTER OPENING THE OUTER PACKAGING BOX, IT WAS OBSERVED THAT THE INNER PACKAGING WAS BROKEN. THE CUSTOMER WAS WORRIED ABOUT THE STERILITY ISSUE OF THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134095 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF TWO FUSION OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR COMBO PACKS, WHEN SORTING THE PRODUCTS, IT WAS REPORTED THAT THE OUTER PACKAGES WERE DAMAGED, SO REPLACEMENTS WERE REQUESTED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133364 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF TWO FUSION OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR COMBO PACKS, WHEN SORTING THE PRODUCTS, IT WAS REPORTED THAT THE OUTER PACKAGES WERE DAMAGED, SO REPLACEMENTS WERE REQUESTED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133352 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT THE ST ERILE PACKAGING WAS DAMAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052107 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR (CVR) , IT WAS REPORTED THAT DURING THE PREPARATION FOR EXTRACORPOREAL CIRCULATION SURGERY IN THE OPERATING ROOM, AN INTEGRATED MEMBRANE OXYGENATOR WAS SELECTED TO USE. THE STERILE PACKAGING OF THE PRODUCT WAS FOUND RUPTURED AND DAMAGED AFTER OPENING THE PACKAGE, SO IT WAS IMMEDIATELY REPLACED WITH ANOTHER OXYGENATOR. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO MISSING, WRONG DEVICES OR COMPONENTS IN THE PACKAGE?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052065 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT DURING THE PROCESS OF PREPARING THE GOODS FOR THE OPERATING ROOM, THE WAREHOUSE STAFF OBSERVED THAT THE INNER PACKAGING WAS DAMAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051995 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION CARDIOTOMY/VENOUS RESERVOIR, IT WAS REPORTED THAT THE PACKAGING WAS DAMAGED. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFOR MATION THAT THE DAMAGE WAS IN THE INNER PACKAGING/TRAY. THE STERILE SEAL WAS NOT INTACT. THE DEVICE WAS NOT SEALED/LOCATED IN THE 'SEAL'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051949 ↗
• MalfunctionJan 9, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS (CVRS) IT WAS REPORTED THAT WHEN THE AGENT RECEIVED THE PRODUCT FOR INSPECTION IN THE WAREHOUSE, IT WAS FOUND THAT THE OUTER PACKAGING OF NINE DEVICES WERE DAMAGED, AND THE ASEPTIC PACKAGING OF THE DEVICE INSIDE WAS FOUND TO BE SQUEEZED AND PARTIALLY CRACKED. THE PRODUCTS COULD NOT BE SENT TO THE HOSPITAL AS THE HOSPITAL REFUSED TO ACCEPT THEM. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WEREN'T ANY MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. THE STERILE SEAL WAS INTACT. HOWEVER, THERE WAS SEVERE SQUEEZE MARK. THE DEVICES WERE LOCATED IN THE SEAL. THE SALES REP CONFIRMED THAT ALL THE DAMAGED PACKAGING BELONGED TO THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019197 ↗
• MalfunctionDec 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR AND FUSION CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT THE PACKAGING HAD STRONG SIGNS OF DAMAGE BEFORE THE BODY CIRCULATION SURGERY. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LOCATION OF THE DAMAGE APPEARANCE WAS AT THE INNER PACKAGING. THE APPEARANCE OF THE DAMAGE WAS A HOLE. THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE SEAL WAS INTACT. THE DEVICE WAS LOCATED IN THE 'SEAL'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849889 ↗
• MalfunctionDec 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED THE STERILE PACKAGING, IT WAS FOUND THAT THE PRODUCT WAS DAMAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830960 ↗
• MalfunctionDec 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR(CVR), IT WAS REPORTED THAT THE OXYGENATOR LEAKED AT THE BOTTOM. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20889959 ↗
• MalfunctionDec 5, 2024Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR (CVR), IT WAS REPORTED THAT THE PARTS WERE FALLING OFF THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853064 ↗
• MalfunctionJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR, THE CUSTOMER REPORTED A FLUID LEAK ISSUE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO OBVIOUS RUPTURE/DAMAGE OBSERVED TO THE DEVICE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK WAS AT THE TUBING CONNECTION. THERE WAS A LEAKAGE AT THE JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557149 ↗
• MalfunctionApr 10, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT DURING THE TRANSFER PROCESS, BLOOD WAS DRAWN TO NEGATIVE PRESSURE. THERE WAS A PROBLEM WITH REMOVING THE BUBBLES AND THERE WERE BUBBLES IN THE BLOOD STORAGE TANK. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077691 ↗
• MalfunctionFeb 8, 2024Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR AND FUSION CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT WHILST PERFORMING AN EXTRACORPOREAL CIRCULATION SUPPORT FOR A SIMPLE ATRIAL DEFECT SURGERY, THE CUSTOMER THAT THE VACUUM-ASSISTED VENOUS DRAINAGE (VAVD) PIPELINE WAS OOZING BLOOD ABOUT 1 HOUR AFTER TURNING THE DEVICE ON, AND FOAM APPEARED ON THE TOP. THE CUSTOMER STATED THAT THEY OBSERVED SMALL INCONSPICUOUS BUBBLES ON TOP OF THE LIQUID SURFACE . THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK WAS AT THE TUBING CONNECTION. THE LOCATION OF THE LEAK WAS AT THE VAVD SIDE INTERFACE. THERE WAS LESS THAN 5ML OF PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK. THERE WAS NO TRANSFUSION REQUIRED. THE RECIRCULATION PORT WAS NOT USED DURING PRIMING OR DURING THE CASE. THERE WERE NOT LARGE AMOUNTS OF SUCTION AND VENTING USED. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. A BUBBLE DETECTOR OR ANY OTHER BUBBLE COUNTER WAS NOT USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18668354 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132972, K203111. One submission often covers many models, so check the product and lot details in each record.

• Z-1027-2023 · Dec 12, 2022 · Open, Classified
  Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
• Z-1025-2023 · Dec 12, 2022 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
• Z-1026-2023 · Dec 12, 2022 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
• Z-1028-2023 · Dec 12, 2022 · Open, Classified
  Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
• Z-1023-2023 · Dec 12, 2022 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
• Z-0531-2015 · Oct 31, 2014 · Terminated
  The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant f