Affinity Fusion™ BB841Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00763000834234), received between Oct 31, 2024 and Sep 30, 2026 — classified as 1 injury, 43 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (25 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, 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 ↗
• 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 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION HOLLOW FIBER OXYGENATOR, IT WAS REPORTED THAT THE OXYGENATOR WAS LEAKING BLOOD. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 24249014 ↗
• MalfunctionJan 29, 2026Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION CARDIOTOMY VENOUS RESERVOIR (CVR), IT WAS REPORTED THAT THE CUSTOMER OBSERVED DENSE LARGE BUBBLES IN THE BLOOD WITHIN THE RESERVOIR OF THE OXYGENATOR, INDICATING A RISK OF AIR ENTERING THE CLOSED EXTRACORPOREAL CIRCULATION SYSTEM. SEE ATTACHED PHOTOS. 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 24210193 ↗
• MalfunctionJan 29, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO USE OF FUSION OXYGENATORS AND FUSION CARDIOTOMY VENOUS RESERVOIRS, THE OUTER PACKAGING, INNER PACKAGING AND STERILE BARRIERS WERE DAMAGED. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT IMPACT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ALLEGATION IS AGAINST TWO DEVICES AND ARE BOTH FROM THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209278 ↗
• MalfunctionJan 29, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO USE OF FUSION OXYGENATORS AND FUSION CARDIOTOMY VENOUS RESERVOIRS, THE OUTER PACKAGING, INNER PACKAGING AND STERILE BARRIERS WERE DAMAGED. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT IMPACT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ALLEGATION IS AGAINST TWO DEVICES, AND ARE BOTH FROM THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209209 ↗
• MalfunctionJan 28, 2026Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION CARDIOTOMY VENOUS RESERVOIRS, IT WAS REPORTED THAT AFTER OPENING THE OUTER PACKAGING BOX, IT WAS SEEN THAT THE INNER PACKAGING WAS DAMAGED. THE CUSTOMER WAS CONCERNED ABOUT THE STERILITY OF THE OXYGENATOR, SO IT WAS NOT USED AND WAS DISCARDED DIRECTLY. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199443 ↗
• MalfunctionJan 28, 2026Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION CARDIOTOMY VENOUS RESERVOIRS, IT WAS REPORTED THAT AFTER OPENING THE OUTER PACKAGING BOX, IT WAS SEEN THAT THE INNER PACKAGING WAS DAMAGED. THE CUSTOMER WAS CONCERNED ABOUT THE STERILITY OF THE OXYGENATOR, SO IT WAS NOT USED AND WAS DISCARDED DIRECTLY. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199377 ↗
• MalfunctionJan 26, 2026Gas Output Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR DEVICE, IT WAS REPORTED THAT THE PATIENT'S CARBON DIOXIDE COULD NOT BE CLEARED. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24175982 ↗
• MalfunctionJan 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS DETECTED IN THE FUSION OXYGENATOR DURING PRIMING PRIOR TO USE. THE ISSUE WAS SUSPECTED TO BE RELATED TO IMPACT DURING TRANSPORTATION. 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 24175973 ↗
• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR, THE CUSTOMER REPORTED THAT THE PACKAGING WAS DAMAGED. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143287 ↗
• MalfunctionJan 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF THE FUSION OXYGENATOR, A BLOOD LEAK WAS OBSERVED FROM THE BOTTOM OF THE DEVICE. 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 24017775 ↗
• MalfunctionJan 5, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT PACKAGING DAMAGE WAS OBSERVED WITH THE FUSION OXYGENATOR AND FUSION CARDIOTOMY VENOUS RESERVOIR (CVR) PRIOR TO USE. 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 23957192 ↗
• MalfunctionDec 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION HOLLOW FIBER OXYGENATOR, IT WAS REPORTED THAT A LEAK WAS OBSERVED FROM THE BOTTOM OF THE OXYGENATOR. SEE ATTACHED PHOTOS/VIDEO. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906611 ↗