Affinity Fusion™ CB811 (UDI 00643169785731)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169785731), received between Jan 6, 2023 and Aug 31, 2023 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K142784); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THE CUSTOMER SET UP AND PRIMED OXYGENATOR PER PROTOCOL WITH NO ISSUES. HEPARIN, SODIUM BICARBONATE, AND MANNITOL WERE USED IN PRIME. HMS PLUS WAS USED FOR ANTI-COAGULATION MONITORING. CARDIOPULMONARY BYPASS (CPB) WAS INITIATED AND ALL LOOKED NORMAL. AFTER A FEW MINUTES, THE PERFUSIONIST NOTICED THAT THE FLOW WAS TRENDING DOWN WITH THE SAME RPMS ON 560 BIO-CONSOLE. ARTERIAL LINE PRESSURE WAS GOING DOWN AS WELL. THIS CUSTOMER HAS EXPERIENCED HIGH PRESSURE EXCURSION (HPE) BEFORE AND KNOWS THAT SOMETIMES IT IS A TRANSIENT ISSUE MEANING THAT AFTER A FEW MINUTES IT RESOLVES ITSELF. THE CUSTOMER ALERTED THE SURGEON AND THEY DID NOT PLACE THE CROSS CLAMP IN ORDER TO SEE IF THE SITUATION WOULD RESOLVE. AFTER 20 MINUTES THE SUSPECTED HPE HAD NOT IMPROVED. AFTER 20 MINUTES THE CARDIAC INDEX WAS DOWN TO 0.5. TARGET FLOW WAS 4.4-4.9 AND WITH THE CI AT 0.5 THE FLOW WAS A LITTLE OVER 2 LITERS/MIN AFTER 20 MINS. THIS IS AS HIGH AS HE COULD GET THE FLOWS TO GO WITH MAX RPMS. THE ARTERIAL LINE PRESSURE REMAINED LOW. THE PERFUSIONIST HAD FILLED THE PATIENT SO SHE WAS EJECTING AND ANESTHESIOLOGIST HAD TURNED TH

  Patient problems: Reduced Blood Flow

  MAUDE report 17659840 ↗
• MalfunctionJun 16, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A FUSION OXYGENATOR, THE CUSTOMER REPORTED THAT WHILE REMOVING THE PROBE THE PORT PULLED WITH IT DURING TEAR DOWN. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17141567 ↗
• MalfunctionJun 6, 2023Break; Fluid/Blood Leak; Material Puncture/Hole; Break; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT AT THE END OF THE CASE THE TEMPERATURE PROBE PORT BROKE AND A BLOOD LEAK OCCURRED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069149 ↗
• MalfunctionMay 30, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT WHILE DISMANTLING THE TUBING FROM THE HEART LUNG MACHINE POST OPERATIVELY, THE ARTERIAL TEMP PROBE ON THE OXYGENATOR SLIPPED OUT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17018140 ↗
• MalfunctionApr 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THE CUSTOMER SET UP THE PUMP AND PRIMED IT WITH FLUID. FLUID BEGAN TO LEAK OUT OF THE TOP SEAL OF THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT THE PACKAGING WAS INTACT AND THERE WAS NO VISIBLE DAMAGE TO OXYGENATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689130 ↗
• MalfunctionApr 6, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT WHEN THE CUSTOMER WAS SETTING UP THE HEART AND LUNG MACHINE (HLM) AND CUSTOM TUBING PACK FOR SECOND CASE THEY NOTICED THE TEMPERATURE MONITORING ADAPTER (TMA) FROM THE PREVIOUS CASE STILL ATTACHED TO THE TEMPERATURE PROBE. THE CUSTOMER NOTED THAT NO PERFUSIONIST DISCONNECTED THE CIRCUIT FROM THE HLM AND IT WAS IN FACT THE ANESTHETIST. AS SUCH, THE CUSTOMER CANNOT BE SURE IF ANY TORQUE WAS APPLIED, BUT IT APPEARED FROM TEMPERATURE PORT, WITH TMA STILL ATTACHED, THAT THE TMA DISLODGED WITHOUT MUCH EFFORT. THE CUSTOMER DID NOT NOTICE ANY RESISTANCE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER WAS UNSURE HOW THE TMA DETACHED FROM THE PORT. IT WAS NOT IDENTIFIED AS BEING LOOSE WHEN THE PACKAGE WAS OPENED AND THE TMA WAS NOT TESTED. AS NOTED, THIS HAPPENED DURING THE FIRST CASE AND WHEN THE CUSTOMER WENT TO SET UP FOR THE SECOND CASE, THEY NOTICED THE TMA STILL ATTACHED THE TEMPERATURE PROBE. THE CUSTOMER DOES NOT BELIEVE MUCH FORCE WAS APPLIED WHEN THEY DISCONNECTED THE TEMPERATURE PROBE FROM THE TMA AND DID NOT NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688966 ↗
• MalfunctionMar 29, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THE CIRCUIT WAS USED WITHOUT INCIDENT AND THEY CAME OFF BYPASS WITH THE TEMPERATURE PROBE REMOVED FROM FUSION TEMPERATURE MONITORING ADAPTER (TMA). THERE WAS A NEED TO GO BACK INTO BYPASS AND WHEN THE PROBE WAS REATTACHED, BLEEDING OCCURRED FROM THE PORT. ONCE THE TEMPERATURE PROBE WAS SECURED, THE BLEEDING STOPPED. THE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED THAT ABOUT 10 MLS OF BLOOD WAS LOST. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TMA PORT DID NOT NOTICEABLY DETACH IN THE INCIDENT. THE PERFUSIONIST REPORTED THAT WHEN THEY WENT TO PUT THE TEMPERATURE PROBE IN AGAIN WHEN GOING BACK TO BYPASS, BLOOD SPURTED OUT OF THE PORT INTO THEIR HAND BUT STOPPED WHEN THE PROBE WAS PLACED IN THE TMA. THERE WAS NO TRANSFUSION REQUIRED AS A RESULT OF THE LEAK. THERE WAS NO DAMAGE TO THE PACKAGING. THERE WAS NO DAMAGE TO THE DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16634193 ↗
• MalfunctionMar 22, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT DURING ROUTINE PRIMING, THERE WAS A SIGNIFICANT CUT/CRACK OBSERVED IN THE PURGE LINE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591462 ↗
• InjuryMar 14, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THE PATIENT HAD A FAILED TRANSCATHETER MITRAL VALVE IMPLANT AND THEIR CONDITION WAS UNSTABLE AND DECLINING, SO AN EMERGENCY PRIME AND CRASH BYPASS WAS PERFORMED. THE CUSTOMER WAS NOT SURE IF THERE WAS A LEAK DURING PRIMING THAT WAS MISSED DUE TO EMERGENCY OF THE SITUATION BUT NOTED IT WAS A VERY SLOW LEAK AT ABOUT 1 DROP EVERY 5 SECONDS. IT IS NOT BELIEVED THAT THE PATIENT CONTRIBUTED TO INCIDENT. 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 A BLOOD LEAK OF 0.2 MLS/ 5 SEC ON AVERAGE. THAT IS 2.4ML/MIN OVER 208 MINUTES WHICH IS ABOUT 500MLS OF BLOOD LOSS, AND THE PATIENT WAS TRANSFUSED WITH TWO UNITS OF BLOOD. THE LEAK WAS NOTICED AFTER BYPASS COMMENCED, WITHIN 10 MINUTES OF COMMENCING BYPASS. THE LEAK CONTINUED UNTIL THE PATIENT WAS WEANED FROM BYPASS. THERE WERE MULTIPLE REASONS FOR THE NEED OF A TRANSFUSION, WHICH INCLUDE BUT MAY NOT BE LIMITED TO: LOW BLOOD VOLUME/ PRESSURE, AND BLOOD LOSS FROM SURGERY. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TEMPERATURE MONITOR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16538357 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE FUSION OXYGENATOR, IT WAS REPORTED THAT DURING ROUTINE SET-UP/PRE-BYPASS THE CUSTOMER OBSERVED THAT THE TEMPERATURE PROBE ON THE OXYGENATOR DETACHED DURING TYPICAL INSERTION WHICH DID NOT INCLUDE ANY TORQUE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECTS OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT PRE-BYPASS SETUP WAS DONE WITH PRIME. THE ARTERIAL TEMPERATURE PROBE WAS INSERTED AS NORMAL AND THE TEMPERATURE PORT BECAME DISLODGED CAUSING A LEAKAGE OF PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485694 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT WHILE PRIMING THE CIRCUIT, IT LOOKED LIKE THERE WAS A BEAD OF PRIME ON TOP OF THE ARTERIAL TEMPERATURE PROBE PORT ON THE OXYGENATOR. UPON FURTHER INSPECTION, IT WAS DISCOVERED TO BE A BEAD OF ADHESIVE. WHEN IT WAS ATTEMPTED TO WIPE AWAY THE PRIME, THE ENTIRE HOUSING OF THE TEMPERATURE PORT TURNED AN OPAQUE WHITE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485219 ↗
• MalfunctionFeb 9, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, THE CUSTOMER REPORTED A TEMP PORT LEAK AND PRIOR TO THE USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A KINK IN THE GREEN GAS TUBING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING. THE KINK WAS FOUND IN THE STERILE PACKAGING. THERE WAS NO VISIBLE AIR IN SYSTEM/TUBING. THE KINK IN THE CUSTOM TUBING PACK WAS DISCOVERED STRAIGHT OUT OF THE PACKAGING. THE LEAK IN TEMP PORT WAS DISCOVERED DURING PRIMING. A PERFUSIONIST INSERTED THE TEMP PROBE AND THEN THE PERFUSIONIST WHO WAS PUMPING THE CASE DID NOT LIKE SOMETHING ABOUT THE SETUP. THEY REMOVED THE TEMP PROBE AND NOTICED A LEAK AFTER REMOVAL. THERE WAS NO ADDITIONAL MANIPULATION OF THE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16332796 ↗
• MalfunctionJan 6, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION HOLLOW FIBER OXYGENATOR, THE CUSTOMER REPORTED THAT THE TEMPERATURE PROBE SITE CAME LOOSE DURING PRIMING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112147 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142784. One submission often covers many models, so check the product and lot details in each record.

• Z-0826-2017 · Nov 16, 2016 · Terminated
  Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Art