Affinity NT™ 541BRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00763000187842), received between Sep 29, 2022 and Sep 28, 2026 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (20 reports).

1 FDA recall record name this device's identifier, 1 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, 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. Sep 12, 2025Open, Classified

   Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.

   Z-0487-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Crack; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926624 ↗
• MalfunctionAug 4, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50126890 ↗
• MalfunctionJun 8, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY NT OXYGENATOR DURING PRIMING, A WATER LEAK WAS OBSERVED FROM THE TEM PERATURE MONITORING ADAPTER (TMA) PORT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427800 ↗
• MalfunctionJun 8, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY NT OXYGENATOR, IT WAS REPORTED THAT A BLOOD LEAK WAS OBSERVED FROM THE TEMPERATURE MONITORING ADAPTER (TMA) PORT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25427548 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN AFFINITY NT OXYGENATOR WAS FOUND LEAKING AT THE TIME OF PRIMING. 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 25214149 ↗
• MalfunctionApr 28, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY NT OXYGENATOR, IT WAS REPORTED THAT A LEAKAGE WAS OBSERVED FROM THE OXY, DURING CARDIOPULMONARY BYPASS. SEE ATTACHED PHOTOS/VIDEO. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 25016910 ↗
• MalfunctionApr 24, 2026Crack; Fluid/Blood Leak; Air/Gas in Device

  (PLI 10, 20): MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A AFFINITY NT CVR (CARDIOTOMY VENOUS RESERVOIR), AND A PIXIE HOLLOW FIBER OXYGENATOR IT WAS REPORTED THAT THE AFFINITY RESERVOIR HAD A CRACK AT THE CONNECTION POINT, RESULTING IN BUBBLE FORMATION AND THE PIXIE OXY HAD A LEAKAGE BETWEEN THE HEAT EXCHANGER AND THE MAIN RESERVOIR. SEE ATTACHED VIDEO. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 24982377 ↗
• MalfunctionApr 20, 2026Increase in Pressure

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A AFFINITY NT OXYGENATOR, IT WAS REPORTED THAT THE OXYGENATOR GAVE HIGH LINE PRESSURES DURING THE CASE. 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 24924200 ↗
• MalfunctionApr 2, 2026Fluid/Blood Leak

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

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24762629 ↗
• MalfunctionMar 13, 2026Crack

  IT WAS REPORTED THAT THE AFFINITY NT OXYGENATOR DEVICE EXHIBITED A CRACK AND BREAK AT THE INLET PORT. A COMPLETE CRACK/BREAK DID NOT OCCUR. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587998 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CARDIOPULMONARY BYPASS, SEVERE BLOOD LEAKAGE WAS OBSERVED FROM THE AFFINITY NT OXYGENATOR. 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 24494206 ↗
• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE AFFINITY NT CARDIOTOMY VENOUS RESERVOIRS (CVRS), IT WAS REPORTED THAT WHILE SEPARATING THE MATERIAL TO BE SENT TO CUSTOMERS, IT WAS OBSERVED THAT THE PLASTIC PACKAGING WHERE THE MATERIAL IS FOUND WAS MARKED AND WITH A SMALL TEAR. THE SECOND UNIT THAT WAS IN THE BOX WAS ALSO BROKEN. UPON INSPECTION OF THE UNITS THAT WERE BEING SEPARATED, ALL OF THEM WERE NOTED TO BE TORN OR HAD HOLES. IT WAS DECIDED THAT ALL OF THE OXYGENATORS IN THE FACILITY WOULD BE INSPECTED AND OUT OF THE 6 BATCHES, 4 WERE AFFECTED. OF THE 600 OXYGENATORS, APPROXIMATELY 168 UNITS WERE OUT OF SERVICE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ONE OF THE CRADLES WHERE THE OXYGENATOR WAS LOCATED WAS SLIGHTLY DAMAGED, BUT IN A DISTANT PLACE WHERE THE PACKAGING WAS BROKEN, BUT THE CARDBOARD BOXES, WHERE THE TWO OXYGENATOR UNITS CAN BE SEEN, WERE ALL INTACT. THE VAST MAJORITY OF THESE BOXES HAD NOT BEEN OPENED, UNTIL AUTHORIZED WAS GIVEN TO INSPECT THEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO DEVICES OR COMPONENTS MISSING OR WRONG IN THE PACKAGE. THE PRODUCTS WERE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151937 ↗
• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE AFFINITY NT CARDIOTOMY VENOUS RESERVOIRS (CVRS), IT WAS REPORTED THAT WHILE SEPARATING THE MATERIAL TO BE SENT TO CUSTOMERS, IT WAS OBSERVED THAT THE PLASTIC PACKAGING WHERE THE MATERIAL IS FOUND WAS MARKED AND WITH A SMALL TEAR. THE SECOND UNIT THAT WAS IN THE BOX WAS ALSO BROKEN. UPON INSPECTION OF THE UNITS THAT WERE BEING SEPARATED, ALL OF THEM WERE NOTED TO BE TORN OR HAD HOLES. IT WAS DECIDED THAT ALL OF THE OXYGENATORS IN THE FACILITY WOULD BE INSPECTED AND OUT OF THE 6 BATCHES, 4 WERE AFFECTED. OF THE 600 OXYGENATORS, APPROXIMATELY 168 UNITS WERE OUT OF SERVICE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ONE OF THE CRADLES WHERE THE OXYGENATOR WAS LOCATED WAS SLIGHTLY DAMAGED, BUT IN A DISTANT PLACE WHERE THE PACKAGING WAS BROKEN, BUT THE CARDBOARD BOXES, WHERE THE TWO OXYGENATOR UNITS CAN BE SEEN, WERE ALL INTACT. THE VAST MAJORITY OF THESE BOXES HAD NOT BEEN OPENED, UNTIL AUTHORIZED WAS GIVEN TO INSPECT THEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO DEVICES OR COMPONENTS MISSING OR WRONG IN THE PACKAGE. THE PRODUCTS WERE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151911 ↗
• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE AFFINITY NT CARDIOTOMY VENOUS RESERVOIRS (CVRS), IT WAS REPORTED THAT WHILE SEPARATING THE MATERIAL TO BE SENT TO CUSTOMERS, IT WAS OBSERVED THAT THE PLASTIC PACKAGING WHERE THE MATERIAL IS FOUND WAS MARKED AND WITH A SMALL TEAR. THE SECOND UNIT THAT WAS IN THE BOX WAS ALSO BROKEN. UPON INSPECTION OF THE UNITS THAT WERE BEING SEPARATED, ALL OF THEM WERE NOTED TO BE TORN OR HAD HOLES. IT WAS DECIDED THAT ALL OF THE OXYGENATORS IN THE FACILITY WOULD BE INSPECTED AND OUT OF THE 6 BATCHES, 4 WERE AFFECTED. OF THE 600 OXYGENATORS, APPROXIMATELY 168 UNITS WERE OUT OF SERVICE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ONE OF THE CRADLES WHERE THE OXYGENATOR WAS LOCATED WAS SLIGHTLY DAMAGED, BUT IN A DISTANT PLACE WHERE THE PACKAGING WAS BROKEN, BUT THE CARDBOARD BOXES, WHERE THE TWO OXYGENATOR UNITS CAN BE SEEN, WERE ALL INTACT. THE VAST MAJORITY OF THESE BOXES HAD NOT BEEN OPENED, UNTIL AUTHORIZED WAS GIVEN TO INSPECT THEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO DEVICES OR COMPONENTS MISSING OR WRONG IN THE PACKAGE. THE PRODUCTS WERE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151825 ↗
• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE AFFINITY NT CARDIOTOMY VENOUS RESERVOIRS (CVRS), IT WAS REPORTED THAT WHILE SEPARATING THE MATERIAL TO BE SENT TO CUSTOMERS, IT WAS OBSERVED THAT THE PLASTIC PACKAGING WHERE THE MATERIAL IS FOUND WAS MARKED AND WITH A SMALL TEAR. THE SECOND UNIT THAT WAS IN THE BOX WAS ALSO BROKEN. UPON INSPECTION OF THE UNITS THAT WERE BEING SEPARATED, ALL OF THEM WERE NOTED TO BE TORN OR HAD HOLES. IT WAS DECIDED THAT ALL OF THE OXYGENATORS IN THE FACILITY WOULD BE INSPECTED AND OUT OF THE 6 BATCHES, 4 WERE AFFECTED. OF THE 600 OXYGENATORS, APPROXIMATELY 168 UNITS WERE OUT OF SERVICE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ONE OF THE CRADLES WHERE THE OXYGENATOR WAS LOCATED WAS SLIGHTLY DAMAGED, BUT IN A DISTANT PLACE WHERE THE PACKAGING WAS BROKEN, BUT THE CARDBOARD BOXES, WHERE THE TWO OXYGENATOR UNITS CAN BE SEEN, WERE ALL INTACT. THE VAST MAJORITY OF THESE BOXES HAD NOT BEEN OPENED, UNTIL AUTHORIZED WAS GIVEN TO INSPECT THEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO DEVICES OR COMPONENTS MISSING OR WRONG IN THE PACKAGE. THE PRODUCTS WERE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151807 ↗
• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE AFFINITY NT CARDIOTOMY VENOUS RESERVOIRS (CVRS), IT WAS REPORTED THAT WHILE SEPARATING THE MATERIAL TO BE SENT TO CUSTOMERS, IT WAS OBSERVED THAT THE PLASTIC PACKAGING WHERE THE MATERIAL IS FOUND WAS MARKED AND WITH A SMALL TEAR. THE SECOND UNIT THAT WAS IN THE BOX WAS ALSO BROKEN. UPON INSPECTION OF THE UNITS THAT WERE BEING SEPARATED, ALL OF THEM WERE NOTED TO BE TORN OR HAD HOLES. IT WAS DECIDED THAT ALL OF THE OXYGENATORS IN THE FACILITY WOULD BE INSPECTED AND OUT OF THE (B)(4) BATCHES, 4 WERE AFFECTED. OF THE (B)(4) OXYGENATORS, APPROXIMATELY 168 UNITS WERE OUT OF SERVICE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ONE OF THE CRADLES WHERE THE OXYGENATOR WAS LOCATED WAS SLIGHTLY DAMAGED, BUT IN A DISTANT PLACE WHERE THE PACKAGING WAS BROKEN, BUT THE CARDBOARD BOXES, WHERE THE TWO OXYGENATOR UNITS CAN BE SEEN, WERE ALL INTACT. THE VAST MAJORITY OF THESE BOXES HAD NOT BEEN OPENED, UNTIL AUTHORIZED WAS GIVEN TO INSPECT THEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO DEVICES OR COMPONENTS MISSING OR WRONG IN THE PACKAGE. THE PRODUCTS WERE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151782 ↗
• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE AFFINITY NT CARDIOTOMY VENOUS RESERVOIRS (CVRS), IT WAS REPORTED THAT WHILE SEPARATING THE MATERIAL TO BE SENT TO CUSTOMERS, IT WAS OBSERVED THAT THE PLASTIC PACKAGING WHERE THE MATERIAL IS FOUND WAS MARKED AND WITH A SMALL TEAR. THE SECOND UNIT THAT WAS IN THE BOX WAS ALSO BROKEN. UPON INSPECTION OF THE UNITS THAT WERE BEING SEPARATED, ALL OF THEM WERE NOTED TO BE TORN OR HAD HOLES. IT WAS DECIDED THAT ALL OF THE OXYGENATORS IN THE FACILITY WOULD BE INSPECTED AND OUT OF THE 6 BATCHES, 4 WERE AFFECTED. OF THE (B)(4) OXYGENATORS, APPROXIMATELY 168 UNITS WERE OUT OF SERVICE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ONE OF THE CRADLES WHERE THE OXYGENATOR WAS LOCATED WAS SLIGHTLY DAMAGED, BUT IN A DISTANT PLACE WHERE THE PACKAGING WAS BROKEN, BUT THE CARDBOARD BOXES, WHERE THE TWO OXYGENATOR UNITS CAN BE SEEN, WERE ALL INTACT. THE VAST MAJORITY OF THESE BOXES HAD NOT BEEN OPENED, UNTIL AUTHORIZED WAS GIVEN TO INSPECT THEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO DEVICES OR COMPONENTS MISSING OR WRONG IN THE PACKAGE. THE PRODUCTS WERE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151729 ↗
• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE AFFINITY NT CARDIOTOMY VENOUS RESERVOIRS (CVRS), IT WAS REPORTED THAT WHILE SEPARATING THE MATERIAL TO BE SENT TO CUSTOMERS, IT WAS OBSERVED THAT THE PLASTIC PACKAGING WHERE THE MATERIAL IS FOUND WAS MARKED AND WITH A SMALL TEAR. THE SECOND UNIT THAT WAS IN THE BOX WAS ALSO BROKEN. UPON INSPECTION OF THE UNITS THAT WERE BEING SEPARATED, ALL OF THEM WERE NOTED TO BE TORN OR HAD HOLES. IT WAS DECIDED THAT ALL OF THE OXYGENATORS IN THE FACILITY WOULD BE INSPECTED AND OUT OF THE 6 BATCHES, 4 WERE AFFECTED. OF THE 600 OXYGENATORS, APPROXIMATELY 168 UNITS WERE OUT OF SERVICE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ONE OF THE CRADLES WHERE THE OXYGENATOR WAS LOCATED WAS SLIGHTLY DAMAGED, BUT IN A DISTANT PLACE WHERE THE PACKAGING WAS BROKEN, BUT THE CARDBOARD BOXES, WHERE THE TWO OXYGENATOR UNITS CAN BE SEEN, WERE ALL INTACT. THE VAST MAJORITY OF THESE BOXES HAD NOT BEEN OPENED, UNTIL AUTHORIZED WAS GIVEN TO INSPECT THEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO DEVICES OR COMPONENTS MISSING OR WRONG IN THE PACKAGE. THE PRODUCTS WERE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151660 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY NT OXYGENATOR, IT WAS REPORTED THAT THE PACKAGING WAS ALREADY OPENED AFTER THE CUSTOMER OPENED THE OUTSIDE PACKAGING OF THE DEVICE INSIDE THE FACTORY. THE OUTSIDE PACKING WAS INTACT AND THERE WAS NO EVIDENCE OF TAMPERING. 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 PACKAGE. THE STERILE SEAL WAS NOT INTACT, AND THE DEVICE WAS NOT LOCATED IN A SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131369 ↗
• MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF AN AFFINITY NT OXYGENATOR, A WATER LEAKAGE AT THE PRODUCT'S TEMPERATURE DETECTION PORT. 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 23740500 ↗
• MalfunctionDec 4, 2025Gas Output Problem; Gas Output Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE AFFINITY NT OXYGENATOR, THERE WAS INSUFFICIENT OXYGENATION CAPACITY AND INSUFFICIENT CARBON DIOXIDE REMOVAL CAPACITY. THE ISSUE WAS IDENTIFIED AS AN ALLEGED PRODUCT PERFORMANCE PROBLEM WITH THE OXYGENATOR. PCO2 (PARTIAL PRESSURE OF CARBON DIOXIDE) WAS BETWEEN 55.3MMHG AND 55.8MMHG. PO2 (PARTIAL PRESSURE OF OXYGEN) WAS 115.3MMHG. HCT (HEMATOCRIT) WAS 32.7%. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713796 ↗
• MalfunctionDec 3, 2025Gas Output Problem; Gas Output Problem

  IT WAS REPORTED THAT DURING USE OF THE AFFINITY NT OXYGENATOR, OXYGENATION LEVELS WERE REDUCED, WITH MEASUREMENTS DROPPING FROM 340 TO 70. RECURRENT EPISODES OF REDUCED OXYGENATION WERE OBSERVED AFTER SEVERAL CASES. A COMPARISON WITH ANOTHER DEVICE SHOWED NORMAL AND OPTIMAL OXYGENATION LEVELS, INDICATING A DEVICE-RELATED PERFORMANCE ISSUE. THE GAS BLENDERS WERE CHANGED TO NEW ONES, BUT THE REDUCED OXYGENATION PERSISTED WHEN USING THE PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23702654 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY NT OXYGENATOR, IT WAS REPORTED IT LEAKED BLOOD. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23579251 ↗
• MalfunctionNov 7, 2025Gas Output Problem; Gas Output Problem

  IT WAS REPORTED THAT DURING SURGERY USING AN AFFINTY NT OXYGENATOR, POOR OXYGENATION WAS OBSERVED AND THE OXYGEN PARTIAL PRESSURE REMAINED LOW DESPITE AN 80% OXYGEN CONCENTRATION. 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 23494598 ↗
• MalfunctionNov 3, 2025Gas Output Problem; Gas Output Problem

  IT WAS REPORTED THAT AN ALLEGED PRODUCT ISSUE OCCURRED WITH THE AFFINITY NT OXYGENATOR, SPECIFICALLY POOR PRODUCT OXYGENATION. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449721 ↗