Affinity® 95214Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00613994375650), received between May 20, 2022 and Dec 29, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K191029, K241352, K932252); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Fluid/Blood Leak; Gas Output Problem; Air/Gas in Device; Fluid/Blood Leak; Gas Output Problem; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY NT OXYGENATOR, IT WAS REPORTED THAT IT HAD BLOOD LEAKAGE AND PRODUCED FOAM, RESULTING IN DECREASED OXYGENATION EFFICIENCY. 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 23904815 ↗
• MalfunctionMay 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PRIMING, THE INTERFACE OF THE AFFINITY NT OXYGENATOR WAS OBSERVED TO BE DAMAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103478 ↗
• MalfunctionMar 31, 2025Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY NT OXYGENATOR, IT WAS REPORTED THAT THE OXYGENATOR INTERFACE WAS DAMAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729188 ↗
• MalfunctionMar 7, 2025Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT PRIOR TO USE OF AN AFFINITY NT OXYGENATOR ONE INTERFACE WAS FLATTENED AND COULD NOT BE CONNECTED TO THE PIPELINE NORMALLY. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT AFTER OPENING THE PRODUCT PACKAGE THE DEVICE WAS OBSERVED TO BE DAMAGED. THE BOTTOM OF THE HEAT EXCHANGER INTERFACE WAS DAMAGED. THERE WAS NO LEAK OBSERVED ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545462 ↗
• MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF AN AFFINITY NT OXYGENATOR THE DEVICE WAS LEAKING WHILE PERFORMING EXTRACORPOREAL CIRCULATION SUPPORT FOR THE PATIENT. THE DEVICE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21523614 ↗
• MalfunctionJan 14, 2025Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY NT OXYGENATOR, IT WAS REPORTED THAT THE CONNECTION HAD BROKEN PIECES AT THE INTERFACE. 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 (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED. THERE WAS NO DAMAGE OBSERVED TO THE MAIN BODY OF THE OXYGENATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21151890 ↗
• MalfunctionNov 27, 2024Fracture; Material Deformation; Fracture; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS AFFINITY NT OXYGENATOR AND AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT LIQUID LEAKAGE OCCURRED DURING PRE-FILLING BEFORE SURGERY. IN THE SECOND EVENT, DEFORMATION OF THE CONSUMABLE INTERFACE WAS FOUND WHEN THE PACKAGE WAS OPENED BEFORE SURGERY. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796512 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS AFFINITY NT OXYGENATOR AND AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT LIQUID LEAKAGE OCCURRED DURING PRE-FILLING BEFORE SURGERY. IN THE SECOND EVENT, DEFORMATION OF THE CONSUMABLE INTERFACE WAS FOUND WHEN THE PACKAGE WAS OPENED BEFORE SURGERY. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796414 ↗
• MalfunctionMay 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY NT OXYGENATOR, THE CUSTOMER REPORTED A LEAK FROM THE TEMPERATURE PROBE. 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 19389718 ↗
• MalfunctionJan 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY NT OXYGENATOR AND AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT THERE WAS LOSS. THE USE OF THE DEVICE WAS NOT SPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604245 ↗
• MalfunctionJan 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY NT OXYGENATOR AND AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT THERE WAS LOSS. THE USE OF THE DEVICE WAS NOT SPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604232 ↗
• MalfunctionJan 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY NT OXYGENATOR AND AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT THERE WAS A LOSS. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594216 ↗
• MalfunctionOct 19, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS AFFINITY NT OXYGENATOR WAS CRACKED AND DAMAGED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17963443 ↗
• MalfunctionOct 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A AFFINITY NT OXYGENATOR AND AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT DURING AN EXTRACORPOREAL CIRCULATION PROCEDURE, THE CUSTOMER OBSERVED OOZING BLOOD AND THE DEVICE COULD NO LONGER BE USED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE OXYGENATOR LEAKED BLOOD. THE CUSTOMER STATED THAT THE DEVICE ITSELF LEAKED. THE LOCATION OF THE LEAK WAS AT THE OXYGENATOR STORAGE TANK. THERE WAS NO BLOOD LOSS AS A RESULT OF THE LEAK. A TRANSFUSION WAS NOT REQUIRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE DEVICE, THE PACKAGE, OR THE CONTENTS WITHIN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867192 ↗
• MalfunctionSep 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A AFFINITY NT OXYGENATOR, IT WAS REPORTED THAT THE DEVICE WAS LEAKING BLOOD. THE D EVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO IMPACT TO THE PATIENT, THE SURGERY WENT WELL..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17735301 ↗
• MalfunctionSep 11, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A AFFINITY NT OXYGENATOR, THE CUSTOMER REPORTED THAT THE INTERFACE BROKE. 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 17717812 ↗
• MalfunctionAug 16, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, THE CUSTOMER REPORTED A FRACTURED LUER. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.  THE CUSTOMER BELIEVES BROKEN INTERFACE MAY BE DUE TO CRUSHING OF THE INNER INTERFACE AND THE ADJACENT ROTATING DEVICE AND RECOMMENDED THAT THE INTERFACE TUBE NOT BE ATTACHED DURING PACKAGING AND BE PACKAGED SEPARATELY. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING. NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559766 ↗
• MalfunctionJun 20, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A AFFINITY NT OXYGENATOR, THE CUSTOMER REPORTED A BLOOD LEAK FROM THE TEMPERATURE MONITORING PORT. 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 AROUND 30 ML OF PATIENT BLOOD LOSS BEFORE THE OXYGENATOR WAS REPLACED. TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THIS LEAK. THE TEMPERATURE MONITORING ADAPTER (TMA) WAS LOOSE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT IT WAS DISCOVERED DURING PRIME. THE LOOSE TMA WAS NOT FOUND WHEN THE PACKAGE WAS OPENED AND PRE-FLUSHED.

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

  MAUDE report 17161643 ↗
• MalfunctionMay 20, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING PRIMING OF AN AFFINITY NT OXYGENATOR, IT WAS REPORTED THAT A LEAK WAS OBSERVED AT THE ARTERIAL BLOOD OUTLET. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION STATING THAT THERE WAS NO DAMAGED TO THE PACKAGING OR OTHER DEVICES IN THE SAME PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14448069 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191029, K241352, K932252. One submission often covers many models, so check the product and lot details in each record.

• Z-0487-2026 · Sep 12, 2025 · Open, Classified
  Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B