Affinity NTRecalls & reported problems across all models

We found 4 models of Affinity NT by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2022 and Sep 28, 2026 — classified as 1 death, 2 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (22 reports).

1 FDA recall record name at least one of these models by its device 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. 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 NT 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. 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 · Recall details · FDA record ↗

Most reported Affinity NT problems

Affinity NT models

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

• Affinity NT™ 541B

  OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall38 reports
• Affinity NT™ 95215

  OXYGENATOR, CARDIOPULMONARY BYPASS
  1 death4 reports
• Affinity NT™ 95217

  OXYGENATOR, CARDIOPULMONARY BYPASS
  3 reports
• Affinity NT™ CB511

  OXYGENATOR, CARDIOPULMONARY BYPASS
  1 report

Recent Affinity NT adverse event reports

The 15 most recent reports across all models, 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 ↗

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