Affinity FusionRecalls & reported problems across all models

We found 10 models of Affinity Fusion by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 206 adverse event reports in the FDA's MAUDE database, received between Mar 25, 2019 and Sep 30, 2026 — classified as 2 deaths, 10 injuries, 194 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (81 reports).

5 FDA recall records name at least one of these models by its device identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Affinity Fusion recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-1026-2023 · Root cause: Process change control · Recall details · FDA record ↗

2. 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-1025-2023 · Root cause: Process change control · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. 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-1023-2023 · Root cause: Process change control · Recall details · FDA record ↗

5. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported Affinity Fusion problems

Affinity Fusion models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Affinity Fusion® BB811

  OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls90 reports
• Affinity Fusion® BB841

  RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
  2 recalls36 reports
• Affinity Fusion™ CB811

  OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall4 reports
• Affinity Fusion™ CB841

  OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• Affinity Fusion™ BB841

  Reservoir, blood, cardiopulmonary bypass
  44 reports
• Affinity Fusion™ CB811

  OXYGENATOR, CARDIOPULMONARY BYPASS
  13 reports
• Affinity Fusion™ BB811

  OXYGENATOR, CARDIOPULMONARY BYPASS
  2 deaths11 reports
• Affinity Fusion™ RCL841

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  5 reports
• Affinity Fusion® BB841

  RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
  2 reports
• Affinity Fusion® BB841

  Reservoir, blood, cardiopulmonary bypass
  1 report

Recent Affinity Fusion adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50946068 ↗
• MalfunctionAug 6, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159968 ↗
• 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 ↗
• MalfunctionJun 29, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION HOLLOW FIBER OXYGENATOR, IT WAS REPORTED THAT THERE WAS A FLUID LEAK ON THE BOTTOM OF THE DEVICE. 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).THERE WAS NO BLOOD LOSS.THE LEAK WAS FROM THE OXYGENATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25652961 ↗
• MalfunctionApr 8, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR/CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT WHEN IT WAS OPENED, THE PACKAGING WAS FOUND TO BE DAMAGED. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE ITSELF WAS NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814208 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT AFTER UNPACKING AND DURING PRE-FLUSHING OF THE OXYGENATOR, A WATER LEAK WAS OBSERVED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24751430 ↗
• MalfunctionMar 31, 2026Gas Output Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THE DEVICE DID NOT OXYGENATED WELL. 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 24740975 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT DURING THE OXYGENATOR PRIMING PROCESS A SEVERE WATER LEAK WAS OBSERVED. 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 24726687 ↗
• MalfunctionMar 23, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE A SURGICAL PROCEDURE, THE FUSION OXYGENATOR/CARDIOTOMY VENOUS RESERVOIR PACKAGING WAS FOUND TO BE DAMAGED, THE STERILE PACKAGE WAS COMPROMISED, AND THE PRODUCT WAS CONTAMINATED. 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 24660105 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF THE FUSION OXYGENATOR, BLEEDING OCCURRED. THE PRODUCT WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24659915 ↗
• InjuryMar 19, 2026Gas Output Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION HOLLOW FIBER OXYGENATOR, IT WAS REPORTED THAT AFTER THE START OF EXTRACORPOREAL CIRCULATION, AN OXYGEN-AIR BLENDER WAS USED TO PROVIDE ROUTINE VENTILATION TO THE DEVICE AT 2 L/MIN WITH FIO2 AT 70%. IT WAS OBSERVED THAT THE ARTERIAL BLOOD AT THE DEVICE OUTLET APPEARED DARK, AND CONTINUOUS MONITORING SHOWED A SUSTAINED DECREASE IN THE PATIENT'S SVO2 (MIXED VENOUS OXYGEN SATURATION) AND SPO2 (PERIPHERAL CAPILLARY OXYGEN SATURATION). RAPID CHECKS OF THE OXYGEN TUBING, OXYGEN-AIR BLENDER CONNECTIONS, AND BOTH AIR AND OXYGEN PRESSURES REVEALED NO ABNORMALITIES. FIO2 WAS IMMEDIATELY ADJUSTED TO 100% AND FLOW INCREASED TO 4 L/MIN, BUT THERE WAS STILL NO IMPROVEMENT. THE SURGICAL AND ANESTHESIA TEAMS WERE NOTIFIED, AND THE CIRCUIT WAS STOPPED FOR REINFUSION. AFTER SWITCHING TO AN OXYGEN CYLINDER AS THE GAS SOURCE, THE ARTERIAL BLOOD BECAME NOTICEABLY REDDER, SO EXTRACORPOREAL CIRCULATION FLOW WAS GRADUALLY INCREASED TO FULL FLOW. SUBSEQUENT BLOOD GAS ANALYSIS SHOWED A SIGNIFICANT IMPROVEMENT IN ARTERIAL OXYGEN PARTIAL PRESSURE, BUT CARBON DIOXIDE PARTIAL PRESSURE REMAINED ABNORMALLY HIGH. AFTER VENTILATING WITH PURE OXYGEN AT MORE T

  Patient problems: Abnormal Blood Gases; Hypoxia

  MAUDE report 24637071 ↗
• MalfunctionMar 18, 2026Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR AND FUSION CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT FOAM WAS OBSERVED ON THE SURFACE OF THE FUSION CARDIOTOMY VENOUS RESERVOIR.  THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625963 ↗
• MalfunctionMar 12, 2026Fluid/Blood Leak; Gas Output Problem; Air/Gas in Device

  IT WAS REPORTED THAT DURING USE OF THE FUSION OXYGENATOR, THERE WERE ALLEGATIONS OF A BLOOD LEAKAGE, BUBBLING, NO GAS OUTPUT AT THE GAS OUTLET, AND POOR CARBON DIOXIDE REMOVAL. THE PRODUCT WAS REPLACED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580541 ↗
• MalfunctionMar 11, 2026Gas Output Problem

  IT WAS REPORTED THAT DURING THE FUSION OXYGENATOR PERFORMANCE WAS SUBOPTIMAL, RESULTING IN INADEQUATE OXYGENATION AND INSUFFICIENT CARBON DIOXIDE REMOVAL AT STANDARD VENTILATION SETTINGS. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566911 ↗

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